Clinical Research Directory

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.

Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).

Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial

This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions. Critically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed. Clinical speech-language pathologists will complete questionnaires about the interventions. A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.

Healthcare and Community Service Utilisation in Older Survivors of Critical Illness

This prospective observational study will describe healthcare and community service utilisation among older adults who survive critical illness and return to the community following hospital discharge. Participants will be adults aged 65 years or older who have been admitted to an intensive care unit (ICU) for at least 48 hours and survive to hospital discharge. Healthcare and community service use will be assessed during the first 90 days after hospital discharge using weekly telephone surveys, participant-completed health diaries, and review of participants' electronic medical records. The study will describe use of general practitioner, medical specialist, allied health, nursing and community services, as well as self-reported needs and barriers to accessing these services, emergency department presentations, hospital readmissions and mortality. Findings will help inform the development of future models of follow-up care for older survivors of critical illness.

Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle

Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory. To address sleep problems in the ICU, a bundle of interventions to support more normal sleep are provided. These bundles consist of medications such as sedatives and environmental changes such as less frequent times being assessed overnight and noise reduction strategies. Although medications can make patients appear to be sleeping, most medications do not provide patients with restful sleep. More research is needed on medications that better mimick restful sleep. One such medication is dexmedetomidine. When formally measured dexmedetomidine can make sleep appear more like a patient sleeping at home as compared to the hospital. The purpose of this study is to test whether giving a patient in the intensive care unit dexmedetomidine helps have a more restful sleep and possibly be more alert and/or interactive the next day. To see if dexmedetomidine improves sleep, the investigators will compare the quality of sleep of two different groups of participants: one group that receives dexmedetomidine at night for 2 nights in a row and another group that does not. How well one sleeps will be measured, in either group, will be assessed by a portable sleep machine that is attached by several stickers. This study is called a pilot or feasibility study. A pilot study assesses how easy it is to recruit patients, whether the sleep machine is tolerated, and amount of time sleep is measured. It is anticipated that about 50 people will take part in this study. This study should take approximately 2 years to complete, and the results should be known in about 1-2 years thereafter.

Life Sustaining Treatments in Critically Ill Children

Summary of the Research on Withdrawing and Withholding Life-Sustaining Treatment for Critically Ill Children Background Medical treatments require regular evaluation to ensure they align with the patient's best interests, particularly in intensive care where quality of life is often compromised. In the context of critically ill children, the challenge increases as patients may not be fully conscious or capable of expressing their needs and preferences. While intensive care can extend life, end-of-life situations necessitate careful consideration to avoid providing futile treatments that do not benefit the patient. Decision-Making Complexity Identifying when further treatment is beneficial poses significant challenges, influenced by various factors including the wishes of the patient and guardians. Previous studies indicate variability among healthcare providers in treatment decisions, often stemming from personal experiences and emotional responses. However, comparable research focusing on critically ill children in Nordic contexts remains scarce. Medical decisions often require balancing potential benefits against the risks of extended suffering or loss of valuable time at the end of life. A previous survey on end-of-life care in Europe indicated similar attitudes across regions but highlighted the need for cultural considerations. Sweden's distinct social and cultural values, characterized by individualism and secularism, may influence practices surrounding life-sustaining treatment. Research Aims This research aims to investigate the factors affecting decision-making regarding the withdrawal and withholding of life-sustaining treatments for critically ill children in Swedish and Nordic intensive care units (ICUs). It will examine practitioners' experiences, attitudes, and the relative impact of children's autonomy in these decisions, excluding neonatal care. Key scientific questions focus on Physicians' attitudes and challenges regarding treatment withdrawal. Methodology Semi-structured interviews in multiple ICUs to explore ethical dilemmas faced by physicians.

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, hazard ratio (HR) 0.52 (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of severely vitamin D deficient critically ill patients is a promising and inexpensive intervention that requires confirmatory multicenter studies. To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials. In case of benefit, vitamin D treatment in critically ill patients could be immediately implemented worldwide.

Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children

The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians.

Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients

Sleep disturbance is very common among critically ill patients in the intensive care unit (ICU), particularly in older adults after surgery. Poor sleep in the ICU is associated with important complications, including delirium, longer duration of mechanical ventilation, prolonged hospital stay, and increased mortality. Current non-drug approaches to improve sleep, such as reducing noise and light and clustering nursing care, may provide limited benefit and are often difficult to implement consistently. Safe and effective drug treatments for sleep in critically ill older patients remain limited. Lemborexant is a dual orexin receptor antagonist that promotes sleep by blocking wake-promoting pathways in the brain. Unlike many traditional sleep medications, lemborexant has minimal effects on breathing and has been shown to be well tolerated in older adults with insomnia. However, its effects on sleep and delirium have not been studied in critically ill patients. This study is a single-center, randomized, double-blind, placebo-controlled feasibility and pilot trial conducted in the surgical intensive care unit of Siriraj Hospital, Bangkok, Thailand. The study will enroll 100 critically ill postoperative patients aged 65 years or older who are expected to remain in the ICU for at least 48 hours. Participants will be randomly assigned to receive either low-dose lemborexant (2.5 mg) or a matching placebo once nightly for three consecutive nights. All participants will also receive standard non-pharmacologic sleep-promoting care used in the ICU. The main goals of this pilot study are to evaluate the feasibility and safety of administering lemborexant in elderly ICU patients and to explore its potential effects on sleep and delirium. Sleep will be assessed using both subjective questionnaires completed each morning and objective wrist-worn actigraphy to measure sleep duration and sleep stages. Delirium will be assessed twice daily using a standardized delirium screening tool for up to seven days or until ICU discharge. Additional outcomes include medication adherence, adverse events, duration of mechanical ventilation, length of ICU and hospital stay, and in-hospital mortality. The results of this study will provide important preliminary data on the feasibility, safety, and potential benefits of lemborexant in critically ill older adults and will help inform the design of future larger clinical trials aimed at improving sleep and reducing delirium in the ICU.

BIS in ICU Interventional Study

This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery. BIS is a non-invasive, EEG-based monitor that shows a number from 0-100 to reflect level of consciousness. Researchers will compare BIS-guided sedation to standard sedation guided by clinical scales (such as the Richmond Agitation-Sedation Scale, RASS). About 144 participants will be randomly assigned (1:1) to one of two groups at two hospitals in Austria (Medical University of Graz and Klinikum Wels-Grieskirchen). In the BIS group, clinicians will use BIS values and standard care to titrate sedation and will aim to avoid sustained BIS values below 50. In the control group, sedation will follow standard practices using clinical scales; BIS will be recorded but hidden from caregivers. The trial is open-label for treating staff; outcome assessors and data analysts will be blinded. Participants will be in the study during their ICU sedation and mechanical ventilation period (typically more than 6 hours), with follow-up through ICU and hospital discharge. The primary outcome is the time-averaged dose of propofol (mg/kg/h) given during continuous ICU sedation until weaning (up to 72 hours). Secondary outcomes include duration of ventilation and sedation, depth of sedation measures, sedative and catecholamine doses, pulmonary infections (including ventilator-associated pneumonia), ICU and hospital length of stay, delirium, and in-hospital mortality. Risks are minimal and may include mild skin irritation from forehead electrodes. Possible benefits include improved sedation management; benefits are not guaranteed. Taking part is voluntary.

Fluorescent Probe for Assessment of Renal Elimination

Accurate measures of kidney function is important for precision dosing of many medications. The current methods of determining kidney function largely hinge on the use of equations that use common laboratory values such as serum creatinine \& static variables like age \& weight. These are helpful for trending over time, but often are inaccurate during times of medical illness. Other more accurate methods of measuring kidney function include urine collection, although this is not commonly used because of various reasons that make the collection inconvenient or unreliable. The new transdermal glomerular filtration (tGFR) device permits accurate, real-time evaluation of kidney function. This novel method has not been rigorously compared with urine collection \& other methods of determining kidney function in hospitalized patients. The goal of the study is to compare tGFR with other accepted methods of determining kidney function.

Mechanical Insufflation-Exsufflation in Critically Ill Patients

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients

This is a prospective observational physiopathological study aimed at evaluating the immunological and inflammatory determinants associated with the prognosis of patients admitted to intensive care units (ICU). The study will establish multidimensional models predicting one-year survival and the occurrence of nosocomial infections. Patients admitted to ICU undergo routine biological sampling. In addition to these, minimal supplementary samples will be collected for immunological and inflammatory biomarker analysis at admission, day 1, day 4, day 8, ICU discharge or day 28, and at 12 months. Additional samples may be taken during clinically significant events (nosocomial infections, complications).

Ear-Vagus Nerve Stimulation and Body Acupuncture for Gut Motility in Elderly ICU Patients

This study aims to investigate whether acupuncture, specifically a combination of body acupuncture and ear vagus nerve stimulation (taVNS), can improve gastrointestinal function in critically ill elderly patients in the Intensive Care Unit (ICU). Gastrointestinal motility problems, such as delayed stomach emptying and constipation, are common in elderly ICU patients and can interfere with feeding, increase infection risk, and worsen outcomes. This research will test if adding acupuncture to standard care helps patients tolerate tube feeding (enteral nutrition) faster, reduces the need for intravenous nutrition, and improves overall recovery. Participants will be randomly assigned to one of three groups: standard care alone, standard care plus body acupuncture, or standard care plus both body acupuncture and ear vagus nerve stimulation. The study will compare the time it takes to achieve target feeding goals, changes in gastrointestinal function scores, and other clinical outcomes. This single-center, prospective, randomized controlled trial will enroll 60 elderly patients from the Geriatric ICU of Jiangsu Province Hospital and aims to provide evidence for integrating traditional Chinese medicine into critical care practice.

pSOFA Score in Predicting Mortality in Pediatric Intensive Care

This prospective observational cohort study aims to evaluate the predictive performance of the Pediatric Sequential Organ Failure Assessment (pSOFA) score for mortality and selected clinical outcomes among critically ill children admitted to the Pediatric Intensive Care Unit (PICU). A total of 100 children will be enrolled and followed during their PICU stay.

The Intensive Care Platform Trial

Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful. Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations: * They typically only assess a single question related to a single comparison of treatments at a time. * They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive. * There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use. * Trial participants do usually not benefit from the obtained knowledge before the trial concludes. * Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed. With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will: * Directly improve outcomes for ICU patients. * Relieve a strained healthcare system by discarding inefficient or harmful treatments. * Ensure that new treatments are beneficial or cost-effective before implementation. * Lower the costs and burdens of assessing more treatments in the critically ill.

ICU Fluid Utilization Survey in Southeast Asia

The objective of this study is to examine the use of different types of fluids for resuscitation in different phases of fluid management in 3 types of critically ill patients including (1) not bleeding, not septic but need volume resuscitation (representing normal condition), (2) bleeding but not septic (representing normal vascular integrity but with a loss of intravascular colloids), (3) septic (representing the condition with increase vascular permeability and endothelium damage) in the ICU within Southeast Asia. The data are collected by a 10-min online survey administered to included physicians which will be distributed via multiple online channels through representatives of each countries.

Effect of Ventilator Hyperinflation Combined With Body Positioning on Arterial Blood Gases In Patients With Ventilator-Associated Pneumonia : A Randomized Controlled Trial

This study aims to evaluate the effect of ventilator hyperinflation combined with body positioning on arterial blood gases in patients with ventilator-associated pneumonia. Forty-two mechanically ventilated patients will be randomly assigned into two groups receiving the intervention in either supine or lateral decubitus positions. Arterial blood gases will be assessed over a 6-day intervention period. The findings are expected to provide evidence regarding the optimal positioning strategy to enhance the effectiveness of ventilator hyperinflation in improving gas exchange in critically ill patients.

Early Glucose States and 72-Hour Care-Metabolic Clusters in Critically Ill Patients

Blood glucose patterns during critical illness may change together with treatment, nutritional support, organ support, and the frequency of glucose monitoring. This retrospective observational study examines the relationship between glucose patterns identified during the first 24 hours of ICU care and broader care-metabolic patterns identified during the first 72 hours. The study evaluates how these early and later patterns relate to each other and whether the 72-hour clusters are associated with subsequent ICU mortality. The early glucose-state definition is also examined in MIMIC-IV as an external supportive analysis. No treatment or clinical intervention is assigned by the investigators.

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration, measured as days alive and ventilator-free (AVF) through Day 21 (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.

Predicting Early Circulatory Deterioration After Short-Acting Beta-Blocker Treatment in Intensive Care Patients

This retrospective observational study used existing intensive care records to examine whether heart rate and blood pressure measured before short-acting beta-blocker treatment could help predict early signs of worsening circulation recorded after treatment. The study included patients who had received intravenous esmolol or landiolol during routine care. Researchers did not assign treatment or change patient care. The main analysis used records from Zhongshan Hospital, Fudan University. Additional intensive care databases were used to evaluate whether a prediction model developed at this hospital could be applied to other patient populations. The main questions were whether pretreatment heart rate and blood pressure could predict recorded circulatory changes, whether combining these measurements improved prediction over simpler blood pressure measures, and whether differences in blood pressure monitoring affected the findings. The main outcome combined a recorded fall in blood pressure, initiation or escalation of norepinephrine (a medicine used to support blood pressure), or early discontinuation of the same beta-blocker. Blood pressure and norepinephrine changes were assessed during the first three hours after the treatment index, and drug discontinuation during the first hour. External database analyses focused on recorded low blood pressure during the first three hours. The study evaluated prediction among patients who had already received treatment. It was not designed to determine whether beta-blockers caused these events or whether a patient should receive a beta-blocker. Data collection and the analyses described here were completed before registration.

Behavioral Economic & Staffing Strategies in the ICU

The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.

JLU_Nutr_FI Registry: A Prospective Registry of Feeding Intolerance in Critically Ill Patients

This prospective observational cohort study aims to characterize feeding intolerance in critically ill adult patients and to identify clinical, physiological, laboratory, electrophysiological, and imaging factors associated with its development. Within 24 hours after intensive care unit (ICU) admission, participants undergo systematic multimodal assessment, including blood sampling, gastrointestinal electrophysiological measurements, gastric antral ultrasonography with assessment of antral motility, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory variables. Participants are prospectively followed for the occurrence of feeding intolerance and other clinically relevant outcomes. The study will evaluate the incidence, predictors, and risk factors of feeding intolerance and explore whether multimodal measurements obtained within the first 24 hours after ICU admission can improve early prediction of feeding intolerance compared with conventional clinical variables. Additional outcomes include duration of organ support, ICU-free days, ventilator-free days, mortality at 28, 90, and 180 days, and longer-term health-related quality of life assessed using the EQ-5D-5L. The overall objective is to improve understanding of feeding intolerance in critically ill patients, enable early risk stratification, and provide a theoretical basis for future individualized nutritional assessment and management strategies.

Continuous Renal Replacement Therapy Circuit Lifespan in Intensive Care Patients

The goal of this retrospective observational study is to evaluate how long continuous renal replacement therapy (CRRT) circuits remain in use in adult intensive care unit patients and to describe how CRRT pressure measurements change over time. The main questions it aims to answer are: Are higher maximum and mean transmembrane pressure (TMP) values associated with longer CRRT circuit lifespan? Do time-normalized pressure trajectories and cumulative TMP burden differ between circuits with different lifespans? Do access pressure patterns influence the relationship between pressure measurements and circuit lifespan? Researchers will analyze archived CRRT device log files, including access pressure, filter pressure, effluent pressure, return pressure, and TMP measurements. No additional procedures, interventions, or study visits will be required. No directly identifiable patient information will be included in the analytical dataset.