Clinical Research Directory

Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients

The goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. The experimental group was injected with terlipressin perioperative and the control group was injected with placebo

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.

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.

Infliximab for Immune Checkpoint Inhibitor Associated AKI

This is a multi-center, 1:1 randomized pilot study examining the efficacy and safety of infliximab 5mg/kg x 1 paired with 2 weeks of prednisone 1mg/kg per day for 2 weeks versus standard-of-care glucocorticoid therapy (prednisone 1mg/kg/day x 2 weeks followed by a 4 week taper) on the rate and speed of renal recovery from immune checkpoint inhibitor-associated AKI.

The Rhabdomyolysis Evaluation in the Emergency Department (REED) Score

One in three adults over 65 fall annually, with one in five remaining on the floor for greater than one hour, which is referred to as a long lie. Pressure on the National Health Service has resulted in extended stays in the Emergency Department (ED) (sometimes longer than 12 hours) and prolonged ambulance response times. This impacts the older adults who have fallen and remain on the floor. This project aims to develop a risk prediction model (RPM) for use within the ED to understand which older adults (60 years or older) who fall over and remain on the floor for longer than one hour ("long lie") and develop rhabdomyolysis (a serious condition where muscle breaks down and releases substances into the blood that can damage the kidneys) will develop poor outcomes and need admission to hospital for treatment and which patients can be safely discharged home. Aim: To develop a RPM to identify which older adults who have a fall and a long lie and attend the ED develop poor outcomes such as Acute kidney Injury (AKI) \[kidneys suddenly stop working properly\], needing kidney replacement therapy (KRT) \[a treatment that helps kidneys that aren't working properly do their job of cleaning the blood\] and mortality \[death\]. Objectives: 1. Abstract patient level data (e.g. biochemical, demographic, situational, medical history, medication history) from medical records combined with outcomes to understand which variables lead to poor outcomes such as AKI, needing KRT and mortality. 2. Analyse the data using a statistical package (Statistical Package for Social Sciences \[SPSS\]) to develop a RPM with good discriminative abilities \[how well the score can tell high-risk from low-risk patients\]. 3. Demonstrate the ability of the RPM to identify which patients need admission to hospital with treatment and which patients can be safely discharged home.

Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI

Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called ouabain have an increased risk of developing kidney damage. This study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain levels will reduce the risk of developing kidney damage after heart surgery.

Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury

The risk for postoperative acute kidney injury (pAKI), as for any other postoperative complications (PC), comes from a number of interactions between a patient's health before surgery, strength to tolerate surgery and influences on the operating room environment. At this time doctors do not have good tools to predict which patients may be at risk of having this complication. The purpose of this research study is to develop a urine test that can be used to predict the risk for having problems with kidney function after major surgery.

Renal Angina Index for Predicting Acute Kidney Injury in Adult ICU Patients

Acute kidney injury (AKI) is a frequent complication of critical illness and is associated with increased morbidity and mortality. Early identification of patients at risk of progressing to moderate-to-severe AKI may facilitate closer monitoring and timely implementation of kidney-protective strategies. This prospective observational cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 AKI in adult intensive care unit patients. Consecutive eligible patients admitted to the participating adult intensive care unit will be enrolled. The RAI will be calculated 24 hours after ICU admission using routinely available clinical characteristics and the change in serum creatinine between ICU admission and 24 hours. The primary outcome will be the development of KDIGO stage 2 or stage 3 AKI during the subsequent 48 hours. AKI staging will incorporate serum creatinine, urine-output, and renal replacement therapy criteria according to KDIGO definitions. The predictive performance of RAI will be evaluated using receiver operating characteristic analysis and the prespecified RAI threshold of ≥10. Secondary outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.

Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

Multiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery.

Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP \< 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.

CTSN Embolic Protection Trial

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures

Contrast-associated acute kidney injury (CA-AKI) is a potential complication that can occur following exposure to iodinated contrast media during diagnostic and interventional procedures, contributing to prolonged hospital stays, increased morbidity, and higher mortality. Although several clinical risk factors are well-recognized, pre-procedural risk stratification remains challenging. The serum uric acid-to-albumin ratio (UAR) has emerged as a composite biomarker reflecting oxidative stress and inflammation that may help identify vulnerable patients prior to contrast exposure. The primary purpose of this prospective observational cohort study is to evaluate the predictive performance of the pre-procedural uric acid-to-albumin ratio for the development of contrast-associated acute kidney injury. The study will also compare the predictive value of UAR between patients undergoing cardiac procedures, specifically percutaneous coronary intervention (PCI), and those undergoing non-cardiac contrast procedures. A total of 100 adult participants will be enrolled across two groups: 50 patients undergoing PCI and 50 patients undergoing non-cardiac contrast procedures. Baseline venous blood samples will be obtained prior to the procedure to measure serum creatinine, uric acid, and albumin levels. Follow-up kidney function tests will be evaluated at 48 and 72 hours post-procedure to detect the development of CA-AKI and assess the diagnostic accuracy of pre-procedural UAR.

Hamburg Acute Kidney Injury Study (HAKIS)

The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.

Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery

This project aims to conduct an international, prospective, multicentre, observational study to determine the incidence of Postoperative Acute Kidney Injury (PO-AKI) in hospitalized children after noncardiac surgery. Urinary biomarkers are intended to be evaluated as predictors of PO-AKI in the same subjects. The study employs modern standardized classifications for AKI to comprehensively address the issue of PO-AKI in children. Describing the incidence and identifying risk factors for PO-AKI will play a crucial role in developing preventive strategies aimed at reducing associated mortality and morbidity. Furthermore, investigating the relationship between urinary biomarkers of renal injury and PO-AKI will provide valuable insights into assessing postoperative renal function in paediatric patients, especially when repeated blood sampling is not feasible.

Kidney Oxygen Saturation and Neutrophil Gelatinase-associated Lipocalin (NGAL) for Detecting Acute Kidney Injury (AKI) After Cardiac Surgery

Acute kidney injury (AKI) is an important complication following cardiac surgery with cardiopulmonary bypass (CPB). Early identification of patients at risk of AKI may facilitate timely clinical management. This prospective observational study investigated the association of perioperative renal regional oxygen saturation (rSO₂), measured using near-infrared spectroscopy (NIRS), and neutrophil gelatinase-associated lipocalin (NGAL) levels with postoperative AKI. A total of 85 adult patients undergoing elective cardiac surgery with CPB were enrolled. Bilateral renal rSO₂ was measured during four predefined perioperative phases. NGAL levels were evaluated preoperatively and at 24 and 48 hours postoperatively. The primary objective was to assess the discriminatory performance of renal rSO₂ and NGAL, individually and in combination, for identifying postoperative AKI. AKI was defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria during the first seven postoperative days. Secondary objectives included determining the incidence and severity of AKI and investigating associated patient-related and perioperative factors.

Frailty and Outcomes in Critically Ill Patients Receiving CRRT

This nationwide observational cohort study will investigate the association between frailty, chronological age, and clinical outcomes in critically ill patients receiving continuous renal replacement therapy (CRRT) in Sweden. Using data from the Swedish Intensive Care Registry, the study will assess whether the Clinical Frailty Scale (CFS) and other measures of comorbidity and illness severity provide prognostic information beyond chronological age. Outcomes will include 30-day mortality, intensive care unit length of stay, and mortality at 60, 90, and 365 days following intensive care unit (ICU) admission. The study aims to contribute to more individualized assessment of critically ill patients who may require CRRT.

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.

A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial

The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.

NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients

The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (\<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (\<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.

Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy.

This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.

Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery

The purpose of this clinical trial is to assess the efficacy and safety of cell therapy with modified leukocyte cells from the participant himself/herself versus placebo in participants who develop Acute Kidney Injury (AKI) within the first 48 hours after cardiac surgery. The main questions it aims to answer are: * Does cell therapy reduce the recovery time of kidney function? * What medical problems do participants have when receiving cell therapy? Researchers will compare cell therapy with a placebo (a look-alike substance that contains no drug) to see if cell therapy works to treat AKI. The safety of cell therapy with leukocyte cells will also be studied.

A Study to Evaluate the Safety and Feasibility of Continuous Renal Replacement Therapy With Regional Citrate Anticoagulation in a Cohort Critical Ill Patients With Acute Kidney Injury and Presumed Absent Citrate Metabolism

Use of regional citrate anticoagulation in an at risk population with decreased citrate metabolism. This study assesses the feasibility and safety of regional citrate anticoagulation in this population.

Effectiveness of an Evidence-Based Respiratory and Renal Care Training With Case-Based Discussion on Nurses' Clinical Reasoning, Knowledge & Practice, Nurse-Physician Collaboration and Mechanically Ventilated Patient Outcomes in a Tertiary-Level ICU in Bangladesh

This study will evaluate the effectiveness of an evidence-based respiratory and renal care training program combined with case-based discussion on nurses' clinical reasoning, knowledge \& practice, nurse-physician collaboration, as well as selected clinical outcomes among mechanically ventilated patients in a tertiary-level ICU in Bangladesh. The intervention will provide structured education and practical training to ICU nurses on evidence-based respiratory and renal care for mechanically ventilated patients. Case-based discussions will be conducted to promote clinical reasoning, evidence-based decision-making, and nurse-physician collaboration during daily ICU rounds. Nurses' outcomes will be assessed before and after the intervention, focusing on clinical reasoning, knowledge, practice, and nurse-physician collaboration. Patient outcomes will be assessed using historical pre-intervention data and post-intervention data among eligible mechanically ventilated ICU patients, focusing on ventilator-associated events (VAE), ventilator-associated pneumonia (VAP), Acute Kidney Injury (AKI), duration of mechanical ventilation, ICU length of stay, and ICU mortality. The study is intended to determine whether evidence-based respiratory and renal care training with case-based discussion can improve ICU nurses' clinical reasoning, knowledge, practice, nurse-physician collaboration and contribute to improved outcomes among mechanically ventilated patients.

Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study

The purpose of this study is to assess the impact of Acute Kidney Injury (AKI) characteristics on long-term renal prognosis in Intensive Care Unit (ICU) patients.