Clinical Research Directory
Browse clinical research sites, groups, and studies.
378 clinical studies listed.
Filters:
Tundra lists 378 Sepsis clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
This data is also available as a public JSON API. AI systems and LLMs are encouraged to use it for structured queries.
NCT05681442
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria). The study will be a prospective multicentre, randomized, open-label comparative continuous vs. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-16
NCT07834346
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
The goal of this clinical trial is to assess whether clarithromycin, given as an adjunct to standard-of-care antibiotic therapy, can reduce the risk of new infections and secondary sepsis in adult patients hospitalized with community-acquired pneumonia (CAP), sepsis, and sepsis-induced immunoparalysis (SII). The primary objective is to evaluate the effect of clarithromycin on the incidence of new infection, including worsening or recurrence of the initial CAP episode, new infections at other sites, and secondary sepsis during the 28-day follow-up period. Secondary objectives are to investigate the impact of clarithromycin on mortality, sepsis response, type of secondary infection, time to antimicrobial escalation, hospital readmission, quality of life, cost-effectiveness, and biomarkers of sepsis-induced immunoparalysis. Researchers will compare clarithromycin plus standard-of-care antibiotic therapy to placebo plus standard-of-care antibiotic therapy. Participants will: * Receive clarithromycin or placebo, administered orally or intravenously, in addition to standard-of-care antibiotic therapy for up to 7 days. * Be evaluated during treatment and follow-up through Day 28, with additional assessment of mortality, hospital readmission, and health status through Day 90.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-16
6 states
NCT06854640
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death. The main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU). For this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Participants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934. Each participant will be in the study for around 28 days. During the study, the doctors and their study team will: * Take blood and urine samples, * Do physical examinations, * Check vital signs such as body temperature, blood pressure and heart rate, * Examine heart health using electrocardiogram (ECG)
Gender: All
Ages: 18 Years - 85 Years
Updated: 2026-10-16
16 states
NCT07460024
Implementation of Timely Management of Sepsis and Septic Shock Protocol in the Emergency Department and Intensive Care Unit: A Quality Improvement Project at AFHJ
Study Title: Implementation of a Sepsis Management Protocol at Armed Forces Hospital Jazan (AFHJ). Purpose: The purpose of this quality improvement project is to determine if implementing a standardized, evidence-based "sepsis bundle" can improve the care and survival of patients with sepsis and septic shock in the Emergency Department (ED) and Intensive Care Unit (ICU). What the Study Involves: Researchers will implement a specific set of clinical guidelines based on the international Surviving Sepsis Campaign. This include: Using a scoring system (NEWS2 and SOFA) to identify sick patients earlier. Ensuring patients receive five critical treatments (the "one-hour bundle") within 60 minutes of diagnosis, including blood tests, IV fluids, and antibiotics. Comparison: The study will compare the outcomes of 74 patients treated before the protocol was introduced (the "Pre-protocol group") to 46 patients treated after the new protocol was put into effect (the "Protocol group"). Expected Outcome: The goal is to increase the number of patients who receive all necessary treatments within one hour from less than 15% to at least 60%. The study also aims to see if this protocol leads to shorter hospital stays and lower mortality rates.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-16
NCT07869693
Pre-induction Norepinephrine in Septic Patients Undergoing Surgery
This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-10-15
NCT07740304
Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, and it remains a leading cause of death in intensive care units. Even when standard treatment targets such as blood pressure are met, blood flow to the small vessels of the skin and other tissues may remain impaired. This "hidden" poor perfusion may not be detected by routine monitoring, yet it may be linked to worse outcomes. The perfusion index is a simple number obtained from the standard pulse oximeter already placed on a patient's finger. It reflects blood flow in the peripheral tissues, requires no additional procedure, and causes no discomfort. This prospective observational cohort study will examine whether the perfusion index, and especially how it changes over the first 24 hours in the intensive care unit, can help predict death within 28 days in adults with sepsis or septic shock. Capillary refill time and skin mottling score will be recorded as additional bedside measures of peripheral perfusion. No treatment will be changed for the purpose of this study, and no additional blood samples or invasive procedures will be performed. All care decisions remain with the treating team. Measurements will be taken at intensive care admission and at 6 and 24 hours. Participants will be followed for 28 days, with survival status also recorded at 90 days. The study will be conducted at two centers. A prediction model will be developed in the first center and then tested, without modification, in patients enrolled at the second center.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-14
2 states
NCT07813767
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
The goal of this clinical trial is to demonstrate the clinical benefit of early intervention with meropenem in adult patients of both sexes with suspected infection and risk of sepsis. The primary objective is to evaluate the clinical benefit of a protein called Pancreatic Stone Protein (PSP), which, if elevated, indicates that patient may be at increased risk of developing sepsis. The secondary objectives are to investigate the impact of early antibiotic treatment with meropenem on progression to sepsis, survival and mortality. Researchers will compare meropenem to a placebo (a look-alike substance that contains no drug). Participants will: * Take a single dose of meropenem or a placebo * Be evaluated at designated timepoints post administration until their discharge and, also, on days 28 and 90 post administration, respectively.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-14
6 states
NCT07811544
Immune Evaluation for Postoperative Sepsis-AKI
This prospective, multicenter, observational cohort study plans to enroll over 800 patients with postoperative sepsis from the ICUs of two tertiary hospitals in Beijing. The study will establish a clinical database and biobank for sepsis-associated acute kidney injury (SA-AKI), characterize clinical and immune phenotypes, and develop an immune evaluation system. Using multi-omics and single-cell sequencing, we aim to identify novel immune biomarker panels and explore early warning and risk-stratification strategies based on immune profiling.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-13
1 state
NCT05875740
Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study
Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis. Single-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice. This observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.
Gender: All
Ages: 18 Years - 60 Years
Updated: 2026-10-13
1 state
NCT06624618
Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit
Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-13
1 state
NCT07871305
Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
Septic shock is a life-threatening condition caused by severe infection that leads to dangerously low blood pressure and impaired blood flow to body tissues and organs. In the intensive care unit (ICU), restoring adequate tissue perfusion (blood flow) is essential during resuscitation. While doctors routinely monitor overall blood pressure, microcirculatory blood flow in peripheral tissues, such as the skin of the feet, can remain poor even after general blood pressure targets are reached. The difference between core body temperature and big-toe skin temperature (known as the core-to-big-toe temperature gradient, or ΔT) reflects blood vessel constriction in the extremities. When peripheral blood flow improves, skin temperature rises and this gradient narrows. This prospective observational study aims to evaluate whether serial measurements of the core-to-big-toe temperature gradient significantly change during the first 12 hours of ICU resuscitation in adult patients presenting with septic shock. The study also examines whether changes in this gradient correlate with standard indicators of clinical recovery, including blood pressure, vasopressor medicine requirements, and blood lactate clearance. All enrolled participants will receive standard, evidence-based medical care for septic shock in accordance with current international clinical guidelines; study participation will not interfere with, alter, or delay clinical treatment. Non-invasive measurements will be collected at three time points: at ICU admission (Hour 0), at 6 hours, and at 12 hours. These assessments include core body temperature, big-toe skin temperature measured with a calibrated infrared thermometer, finger capillary refill time, routine arterial blood pressure, and arterial blood lactate levels. If effective, this temperature gradient could provide clinicians with a simple, non-invasive, and cost-effective bedside indicator to monitor peripheral perfusion during critical care resuscitation.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-13
NCT07857928
Effect of Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated ARDS
Sepsis-associated acute respiratory distress syndrome (ARDS) is a severe condition where severe infection causes fluid accumulation in the lungs, often requiring invasive mechanical ventilation. Patients with low blood albumin levels are particularly vulnerable to this fluid leakage, leading to prolonged dependence on a ventilator. This observational study evaluates the association between a targeted human albumin treatment strategy combined with clinically guided fluid removal, and clinical outcomes in adults with sepsis-associated ARDS and low blood albumin levels (≤ 30 g/L). Conducted at a single hospital, this study compares two groups. The prospective group consists of patients receiving current usual clinical care, where albumin administration and fluid management are determined by the treating clinical team. Their outcomes will be compared to a historical control group of similar patients who received standard care before this targeted albumin management strategy was routinely implemented. The primary objective is to evaluate whether this targeted albumin strategy is associated with an increase in Ventilator-Free Days at day 28 (VFD-28). VFD-28 reflects both patient survival and successful liberation from the ventilator. The study will also observe secondary outcomes including oxygenation improvement, fluid balance, organ function, mortality, and safety events (e.g., fluid overload or allergic reactions). As an observational study, researchers do not assign treatments; all interventions are based on real-world clinical judgment.
Gender: All
Ages: 18 Years - 85 Years
Updated: 2026-10-13
1 state
NCT07779720
Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial
The goal of this pilot clinical trial is to learn if a fluid assessment using non-invasive cardiac output monitoring (NICOM) is helpful for patients with sepsis who have low blood pressure in the Emergency Department (ED). The study will measure whether the NICOM assessment changes fluid resuscitation practices and is feasible in the ED setting. All patients will receive standard medical care. Patients assigned to the NICOM group will receive a one-time, non-invasive bedside fluid assessment using NICOM, in addition to standard care, and the results of the fluid assessment will be provided to the treating physician.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-13
1 state
NCT06824350
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and treatment facilities will receive infection prevention and control messaging. The goal of the study is to evaluate the impact of the intervention on bacterial contamination of water supply, on staff hands, and on high-touch surfaces in maternity wards, and the following outcomes among facility-born neonates and their mothers: (1) gut carriage of bacterial pathogens associated with sepsis one week post-birth, (2) gut carriage of antibiotic resistant bacteria one week post-birth, and (3) symptoms of possible serious bacterial infection one week following birth.
Gender: All
Updated: 2026-10-13
1 state
NCT07735741
Immune Dysregulation During Sepsis: A Natural History Cohort
Background: Sepsis is an illness that occurs when the body s immune system runs out of control. This can damage organs. Sepsis causes an estimated 1 in 5 deaths worldwide. In this natural history study, researchers want to learn more about how the immune system changes during sepsis. They hope this knowledge will help them find better ways to treat sepsis. Objective: To understand how sepsis affects the body over time. Eligibility People aged 18 years and older admitted to INOVA Fairfax Hospital in Virginia and who have sepsis. Design: Researchers will collect data from participants medical records. Participants will have blood drawn at least 5 times while they are in the hospital. Blood may be collected for up to 30 days, if they remain in the hospital that long. The blood will be taken from access lines that are already in place. Some blood draws will be optional. Participants may opt to have up to 3 tests of their heart function while they are in the hospital. Some participants may have a sample of fluid collected from their lungs. Participants will have a follow-up visit about 90 days after they join the study. This visit will be by phone call if they have left the hospital. They will fill out a questionnaire. They will answer questions about their health and how they feel. The call will last about 30 minutes.
Gender: All
Ages: 18 Years - 100 Years
Updated: 2026-10-09
1 state
NCT06929494
Candidemia in Critically Ill Patients
Candidal sepsis (candidemia) is a criticals problem in patients hospitalized in the intensive care unit, with a significant impact on morbidity and mortality. Risk factors for candidemia in intensive care patients included age, presence of a central venous catheter, inpatient surgery, and administration of parenteral nutrition (TPN). Mortality in patients with candidemia is estimated at 50-60%. Early identification and treatment, including control of the source of infection, are essential to improve morbidity and mortality in these patients. In this study, we would like to identify risk factors for the development of candidemia in intensive care patients, including those who have not undergone abdominal surgery, and to examine what percentage of patients who developed candidemia were given empirical antifungal therapy and what factors influenced the decision to give or not to give such empirical therapy. Study design: A retrospective study based on data collection from computerized systems will include patients who were hospitalized in the intensive care unit from January 2014 to December 2024 and were diagnosed with Candida in at least one blood culture.
Gender: All
Ages: 18 Years - 99 Years
Updated: 2026-10-09
NCT06541600
Risk Factors for Adverse Outcomes in Sepsis
This multi-phase prospective study utilized Data-Independent Acquisition proteomics on a nested subset (15 SIC vs. 15 matched sepsis) to map early molecular alterations. Guided by gene-set enrichment evidence of extracellular matrix (ECM) disruption as a pathway-derived biomarker. Admission matrix metalloproteinase-3 was validated in 567 critically ill patients (417 sepsis, 150 non-septic controls) across three hospital campuses.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-08
1 state
NCT07859852
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis. Participants enrolled in the study will have blood collected at the same time as blood samples obtained for standard-of-care blood culture testing. Study blood samples will be tested using the UllCORE BSI Test either as fresh samples or after frozen storage, according to the study protocol. The results of the UllCORE BSI Test will be compared with standard-of-care microbiology results and, when applicable, additional testing methods to assess the diagnostic performance of the investigational test. The UllCORE BSI Test results will not be used to guide patient care and will not be provided to treating healthcare professionals for clinical decision-making. Participation in the study will therefore not change the standard medical care received by participants.
Gender: All
Updated: 2026-10-08
10 states
NCT06531031
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.
Gender: All
Updated: 2026-10-08
6 states
NCT07735182
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
Sepsis is a major cause of morbidity and mortality in intensive care units. Sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) are common complications associated with adverse clinical outcomes. Altered gut microbial diversity, microbial metabolites, intestinal barrier dysfunction, and systemic inflammation may contribute to hepato-renal injury during sepsis. However, prospective longitudinal evidence in patients with SALI and S-AKI remains limited. This prospective, multicenter, longitudinal observational cohort study will enroll adult patients with sepsis across eight intensive care units at six medical centers and healthy adult volunteers as a baseline reference cohort. For patients with sepsis, stool and blood samples will be collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Healthy volunteers will provide a single baseline stool and blood sample at enrollment. Fecal microbial alpha diversity and community structure will be assessed by metagenomic sequencing and bioinformatic analysis. Plasma metabolites, including total short-chain fatty acids, indoxyl sulfate, and additional targeted plasma metabolites, will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry. Intestinal barrier and clinical biomarkers will also be assessed. The primary objectives are to evaluate the associations between longitudinal trajectories of fecal microbial alpha diversity, measured by the Shannon diversity index, and the occurrence of SALI and S-AKI within 7 days after sepsis diagnosis. Secondary objectives include evaluating the associations between longitudinal changes in fecal microbial beta diversity and the occurrence of SALI and S-AKI; assessing the associations between longitudinal trajectories of fecal microbial alpha diversity and organ recovery status at Days 14-20 among patients who develop SALI or S-AKI; describing selected plasma metabolite and intestinal biomarker concentrations at prespecified time points; and assessing 28-day all-cause mortality. Exploratory multi-omics analyses will evaluate microbial taxa, microbial functional genes, metabolites, and host biomarkers to identify candidate biomarkers and biological pathways associated with the development and clinical course of sepsis-associated hepato-renal injury.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-07
1 state
NCT07852780
Effect of Adjunctive Ursodeoxycholic Acid on Oxidative Stress, Inflammation, and Organ Dysfunction in Adults With Sepsis
epsis is a life-threatening syndrome characterized by acute organ dysfunction resulting from a dysregulated host response to infection. Despite advances in antimicrobial therapy, source control, hemodynamic resuscitation, and organ-supportive strategies, sepsis continues to be associated with substantial morbidity and mortality. Current management is primarily supportive and does not directly target the interconnected processes of excessive inflammation, oxidative stress, endothelial dysfunction, and cellular injury that contribute to progressive organ dysfunction. Current international guidance emphasizes prompt antimicrobial therapy, source control, hemodynamic resuscitation, lactate assessment, and appropriate organ support as the foundation of management. Oxidative stress is an important component of sepsis pathophysiology. Excessive production of reactive oxygen species, together with impaired endogenous antioxidant defenses, can promote lipid peroxidation, mitochondrial dysfunction, cellular injury, and amplification of inflammatory signaling. Maladaptive activation of inflammatory pathways, including nuclear factor-kappa B (NF-κB), contributes to increased production of pro-inflammatory mediators such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). These processes may contribute to dysfunction of the kidney, liver, lungs, cardiovascular system, and other organs. Ursodeoxycholic acid (UDCA) is a hydrophilic endogenous bile acid with an established clinical safety record and established hepatobiliary therapeutic use. Beyond its conventional hepatoprotective effects, experimental evidence suggests that UDCA may exert antioxidant, anti-inflammatory, anti-apoptotic, cytoprotective, and mitochondrial effects. The rationale for investigating UDCA in sepsis is supported by several lines of evidence. Experimental work has demonstrated that UDCA can attenuate sepsis-induced acute kidney injury through activation of the Nrf2/HO-1 antioxidant pathway and inhibition of NF-κB signaling, accompanied by reductions in TNF-α, IL-1β, IL-6, and renal injury markers. Experimental studies have also demonstrated attenuation of sepsis-associated lung injury, pulmonary barrier dysfunction, oxidative stress, inflammatory cytokine production, and PANoptosis following UDCA administration. Importantly, emerging clinical evidence has begun to investigate UDCA in adult sepsis. A retrospective matched study of critically ill adults with sepsis/septic shock did not demonstrate significant improvement in day-3 SOFA score or vasopressor requirements, although improvement in the PaO₂/FiO₂ ratio and earlier extubation were observed among UDCA recipients. More recently, a small prospective pilot involving eight septic patients receiving UDCA explored its potential effects on sepsis-associated platelet dysfunction, while mechanistic studies implicated TREM2-linked signaling. Therefore, a randomized controlled trial is warranted to determine whether adjunctive UDCA can modify the biological abnormalities underlying sepsis, particularly oxidative stress and inflammation, and whether these effects are accompanied by improvement in organ dysfunction.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-10-07
NCT07863323
Non-invasive Hemodynamic Optimization of Sepsis in Internal Medicine: a Randomized Study Comparing Therapy Guided by Non-invasive Hemodynamic Indices Versus Standard of Care.
Background and Rationale Sepsis affects 20 to 30 million people globally each year, with an estimated 48.9 million cases in 2017. Despite medical advances, it still carries a high risk of death. Since sepsis progresses rapidly, early treatment is essential. This includes not only starting antibiotics quickly but also managing fluid levels effectively. Research suggests that in sepsis, fluid problems are often due to poor distribution in the body rather than an actual lack of fluids. Currently, fluid and blood pressure management is often based only on monitoring arterial pressure, which may not provide a full picture of what's happening in the patient's circulatory system. More advanced indicators like Stroke Volume, Cardiac Output, and Peripheral Vascular Resistance can offer better guidance to optimize treatment and improve outcomes. New non-invasive devices such as NICaS (Non-Invasive Cardiac System) make it easier and faster to monitor these values. NICaS uses electrical impedance technology and is approved by both the FDA and CE. It is easy to use, does not require specialized training, and allows for a more personalized and accurate treatment approach by tracking key heart and circulation parameters in real time. Primary Objective The main goal of this study is to compare two treatment strategies for patients with sepsis admitted to medical wards, and see which one leads to better survival: * Fluid and/or vasopressor therapy guided by non-invasive hemodynamic monitoring (using NICaS), based on values like Stroke Volume, Cardiac Power Index, and Peripheral Vascular Resistance. * Standard fluid therapy based on the international Surviving Sepsis Campaign (SSC) guidelines. Secondary Objectives * Use of vasopressors: Check which strategy leads to less frequent use of vasopressor drugs and shorter treatment duration with them. * Kidney function: See which method is linked to fewer cases needing dialysis or kidney support. * Timing of vasopressors: Understand if giving vasopressors earlier leads to better short- and mid-term outcomes, such as lower death rates after 30 days, fewer ICU admissions, and shorter hospital stays. * Albumin levels and circulation: Track how blood albumin levels change with circulation status, to see if there's a link with fluid leakage (capillary leak) and risk of death. * Fluid balance: Analyze how fluid gains and losses relate to changes in heart and circulation measurements. * Microcirculation: Test if adding signs of small vessel (microcirculation) issues to the main heart and blood flow indicators improves predictions of how patients will do. * Prediction scores: Investigate whether combining NICaS readings with common scoring systems like SOFA or APACHE helps doctors predict patient outcomes more accurately. * Time to stability: Compare how quickly patients in each treatment group recover to a stable condition. According to Rosenthal and Kavic's criteria, a patient is considered stable when: -Their illness is improving -There's low risk of getting worse again - Organ support is stable - There's little chance of new problems arising - There are no major complications. Conclusion This study aims to evaluate whether a more personalized approach using real-time, non-invasive hemodynamic monitoring can lead to better outcomes in septic patients compared to standard care. If successful, this method could help reduce deaths, complications, and treatment costs in sepsis management.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-07
2 states
NCT07716956
Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients
The goal of this clinical trial is to assess the effect of targeting upper normal serum magnesium levels on norepinephrine requirements in adult patients with septic shock. The main questions it aims to answer are: 1. Does maintaining upper normal serum magnesium levels lower the total cumulative dose and duration of norepinephrine therapy? 2. Does this approach reduce the intensive care unit (ICU) length of stay, duration of mechanical ventilation and mortality? This study will compare an intervention group to a control group to see the effect of targeting upper normal serum magnesium levels. Participants will: * Have their serum magnesium levels assessed at baseline (Day 0), at three-day intervals (Days 3, 6, 9) thereafter and on the day of norepinephrine discontinuation. * Receive individualized intravenous magnesium sulfate infusions to achieve and maintain the target serum magnesium levels. * Have their demographic data collected and be monitored closely for clinical data, vital signs, Mean Arterial Pressure (MAP), urine output and laboratory parameters.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-06
1 state
NCT07060560
Presepsin Diagnostic Performance in Severe Burn Sepsis
This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-05
1 state