Clinical Research Directory

Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure

In Intensive Care Unit (ICU) patients with acute kidney injury (AKI) and treated with renal replacement therapy (RRT) often present a fluid overload which is associated with morbidity (mechanical ventilation duration increase, kidney recovery decrease) and mortality. Patients' prognostic could be improved by correcting the fluid overload with net ultrafiltration (UFnet) however it may lead to harmful iatrogenic hypovolemia responsible of deleterious ischemic lesions. In usual practice, UF net prescription are variable and there are different international recommendations. Some observational studies suggest that using a UFnet between 1 et 1.75 mL/kg/h in fluid overloaded patient decrease mortality. Fluid overload increases morbidity and mortality, particularly in RRT. Studies without RRT argue for an efficacy of management by decreasing the fluid overload .Cohort studies suggest to use a moderate UFnet instead of a low UFnet. Some data from studies on early versus late RRT that relate the fluid balance or correct the fluid overload during the early strategy argue for a beneficial effect of an early deresuscitation strategy Consequently, the impact of a moderate UFnet (to decrease the fluid overload) compared to a low UFnet (to stabilize the fluid overload) in a randomized interventional study could be assessed. The study hypothesis is that : an early fluid overload deresuscitation protocol with a high UFnet (2 ml/kg/h) targeting both the negativation of cumulated fluid balance to reach a dry weight and the maintenance of tissue perfusion. Compared to fluid overload deresuscitation protocol with a low UFnet (between 0 and 1 ml/kg/h) to reach a stabilization of cumulated fluid balance without monitoring the tissue perfusion. could improve overall, renal, hemodynamic and respiratory prognosis in fluid overloaded patients with renal replacement therapy in ICU

Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury

Currently, continuous renal replacement therapy (CRRT) is the main modality for renal support in critically ill patients with hemodynamic instability. Most studies have investigated the timing of RRT initiation. However, prolonged CRRT demonstrated the association of many unexpected events, such as catheter-related complications, catheter-related blood stream infection, hypotension, hypothermia, tachycardia, and atrial fibrillation. Up to now, there is a lack of evidence regarding the timing of withholding CRRT. The furosemide stress test (FST) is a tool that is easy to use and has more availability. The investigators aimed to apply FST to evaluate renal recovery compared with standard treatment in critically ill patients undergoing CRRT.

Evaluation of Postoperative Organ Injury, Risk Factors, and Short-Term Clinical Outcomes in Patients Admitted to Intensive Care After Noncardiac Surgery

This retrospective observational study examines whether troponin levels measured before surgery are associated with acute kidney injury during the first 48 hours after surgery in patients admitted to intensive care after noncardiac surgery. Troponin is a protein measured in blood that can indicate heart muscle injury. Acute kidney injury is a sudden decline in kidney function. Existing medical records from 224 patients who underwent emergency or elective surgery will be reviewed. Kidney injury will be assessed using changes in blood creatinine levels and the need for dialysis or other kidney replacement therapy. The study will also examine changes in troponin levels around surgery, length of stay, and survival during hospitalization. No additional tests or treatments are performed for this study.

ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)

The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission. The study will assess how accurately the test predicts acute kidney injury by evaluating its sensitivity, specificity, positive predictive value, and negative predictive value. Participants will provide blood and urine samples for testing.

Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI

This observational study aims to explore the factors that influence the risk of new infections in critically ill patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) in the UK.

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0

There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes. In addition to poor outcomes during the hospitalization, infants discharged from the NICU may have an increased burden of kidney disease during childhood. Studies of long-term kidney function in children born prematurely show a fourfold increase in chronic kidney disease (CKD) by adolescence and into adulthood. Despite the landmark findings of the Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) study, the limitations of this study are notable. First, the AWAKEN study enrolled infants admitted in 2014, making the data now over 10 years old. Much has changed in neonatal practice (e.g. increased AKI awareness, treatment strategies). Secondly, the findings of the AWAKEN study were geographically limited. While the AWAKEN study was multi-national and multi-center, it represented only 24 centers (22 from North America, 1 from India and 1 from Australia). Finally, information collected from AWAKEN ended at hospital discharge. The investigators seek to leverage the strength of the Neonatal Kidney Collaborative along with other organizations and collaboratives interested in neonatal kidney health to address these gaps. Therefore, the investigators are conducting a second, modified iteration of this study entitled "AWAKEN 2.0". AWAKEN 2.0 will be a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study.

LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)

An estimated 10-15% of critically ill patients with acute kidney failure in the intensive care unit receive acute dialysis therapy. The majority of these patients initially receive a continuous form of dialysis therapy call continuous renal replacement therapy (CRRT). Prior studies have suggested that higher CRRT dose-intensity improved health outcomes for these patients; however, this was not found in high-quality clinical trials. These more recent trials suggested a lower range of dose-intensity compared with the higher range as the new standard of care. This was incorporated into guidelines. To date, no clinical trials have evaluated this lower range and specifically, it is plausible that an even lower dose-intensity of CRRT may be well tolerated, safe, associated with similar outcomes and be more cost-effective. This is the objective of the WISDOM trial, to compare the guideline standard with lower dose-intensity among patients who are started on CRRT in the intensive care unit.

Lassa Fever Clinical Course and Prognostic Factors in Nigeria

The investigators propose to conduct a nationwide (Nigeria), prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. Special focuses will be made on situations at risk of bad outcome such as pregnancies, acute kidney injury and electrolytic imbalance in patients with confirmed Lassa fever. Participants for which the diagnosis of Lassa fever will be finally excluded by reverse-transcriptase polymerase chain reaction (RT-PCR) will constitute the control group.

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

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.

Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation

PFA is an emerging non-thermal ablation technology with favorable procedural safety; however, recent studies have raised concerns about peri-procedural hemolysis and subsequent AKI after PFA. This study is a single-center, open-label, randomized controlled trial designed to evaluate whether standardized peri-procedural intravenous hydration can reduce the risk of acute kidney injury (AKI) after pulsed field ablation (PFA) for atrial fibrillation (AF). Eligible adult patients with symptomatic paroxysmal or persistent AF scheduled for PFA will be randomly assigned in a 1:1 ratio to either a standardized hydration strategy or a control strategy without routine prophylactic hydration. The hydration group will receive 0.9% saline at 2 mL/kg/h from entry into the electrophysiology laboratory until 12 hours after the procedure, while the control group will receive no routine preventive hydration and will be treated with fluids only if clinically indicated. The primary outcome is any in-hospital AKI defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints include in-hospital AKI severity by KDIGO stage, in-hospital persistent moderate-to-severe AKI, in-hospital renal replacement therapy, changes in renal function after the procedure, and clinical outcomes through 30 and 90 days, including all-cause death, persistent AKI, renal replacement therapy, all-cause rehospitalization, and composite major adverse events.

Effects of Anesthetic Techniques on Renal Function

This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.

NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial

A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery

Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention

This research trial will test whether using carbon dioxide as a contrast medium during surgery to open blocked leg arteries can prevent kidney injury. One in five people over 55 in the UK suffer with narrowing or blockages in their leg arteries, which is called peripheral arterial disease. It leads to poor leg circulation, which can cause leg gangrene or infection. Sometimes this may even lead to major lower limb amputation. To prevent this from happening, the affected arteries can be opened using endovascular revascularisation. These procedures are the most common artery surgeries in the NHS. To be able to perform these procedures, doctors use an iodine-based contrast medium (dye) injected in the artery, which can negatively affect kidney function. Instead of the usual dye that causes kidney problems, carbon dioxide can be used as it does not damage the kidneys. No previous randomised controlled trial, however, has tested whether using carbon dioxide via automated injectors does indeed protect the kidneys in these procedures. This research will take place in at least six NHS hospitals in the UK. People with peripheral arterial disease and chronic kidney disease who are having a procedure to open their arteries will be asked to take part. Participants will be randomly chosen to have the procedure with carbon dioxide or with standard iodine-based contrast medium. The investigators will then perform blood tests to measure serum creatinine on the 2nd, 30th, and 90th day after the procedure to compare kidney function between the two groups. The investigators will also compare the volume of iodine-based contrast medium used. The study will also include qualitative research into how the hospital staff performing the intervention feel, as well as how participants found the procedure with carbon dioxide.

Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid

The goal of this observational study is to understand whether a wearable sensor (the Nutromics Sensor Device) can accurately measure drug and biomarker levels in the fluid just under the skin (interstitial fluid), instead of needing repeated blood draws, in adults admitted to hospital who are being treated with the antibiotic vancomycin or who are being monitored for signs of sepsis. The main questions it aims to answer are: * How closely do interstitial fluid levels of vancomycin match levels measured in the blood at the same time? * How closely do interstitial fluid levels of creatinine, C-reactive protein, and lactate (biomarkers linked to kidney function, inflammation, and infection severity) match levels measured in the blood? * Can the device pick up on early biomarker trends that signal a patient may be developing acute kidney injury? * How well does the device work overall, and does it perform consistently across different patients (by age, sex, ethnicity, body size, and health conditions) and over time? * Is the device safe to wear? There is no comparison group receiving a different treatment. This study looks at how well the device's readings line up with standard blood tests, not about testing a new treatment. Participants will: * Wear up to two small sensor patches on their upper arm during their hospital stay (up to 5 days), with each patch replaced every 48 hours * Have blood samples taken as part of their routine care so results can be compared * Have their medical records reviewed 30 days after finishing the study to check on their health outcomes

Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery

The goal of this observational study is to learn whether increased pressure inside the abdomen over time is associated with acute kidney injury in adults receiving intensive care after emergency abdominal surgery. The main question it aims to answer is: * Is greater cumulative exposure to increased abdominal pressure associated with a higher risk of acute kidney injury? Participants will have abdominal pressure measured through a urinary catheter during routine intensive care. Researchers will record these measurements and information about kidney function without changing participants' treatment.

Effects of Remote Ischemic Preconditioning at Different Time Phases in Patients Undergoing Heart Valve Surgery

Patients undergoing heart valve surgery require cardiopulmonary bypass, a procedure that can lead to a temporary reduction in blood flow to major organs and subsequent ischemia-reperfusion injury, thereby triggering postoperative complications such as acute kidney injury and delirium. Current treatments for these complications primarily involve pharmacological and non-pharmacological interventions. Pharmacological interventions are not routinely employed due to limited supporting evidence, while non-pharmacological interventions are labor-intensive and lack systemic protective effects; thus, there is an urgent need for a systemic, non-pharmacological intervention that is easy to implement. This study aims to investigate the organ-protective effects of remote ischemic preconditioning-administered at different time points-following heart valve surgery, with the goal of developing a safe, effective, and clinically scalable nursing intervention protocol. Through this research, the investigators hope to further reduce the incidence of postoperative complications and improve clinical outcomes and prognoses for patients undergoing heart valve surgery.

Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury

This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery

This prospective randomized study evaluates the nephroprotective effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit during cardiac surgery with cardiopulmonary bypass.

Amino Acid Therapy Evaluating the Incidence of New-Onset AKI

The goal of this clinical trial is to learn whether giving amino acids through an IV during and after heart surgery can protect the kidneys of children with congenital heart disease. Many children who have heart surgery using a heart-lung (bypass) machine develop a sudden decrease in kidney function, called acute kidney injury (AKI). AKI can lead to a longer hospital stay and other complications, and over time it may raise the risk of long-term kidney disease. Children with congenital heart disease often need more than one heart surgery, so their kidneys may face this risk several times. There is currently no treatment proven to prevent AKI in children after heart surgery. Amino acids are the building blocks of protein. Giving amino acids through an IV increases blood flow and oxygen delivery to the kidneys. In adults having heart surgery, this treatment lowered the chance of kidney injury, but it has not been tested in children. The amino acid solution used in this study, TrophAmine, is already used routinely in children's hospitals as part of IV nutrition. The main questions this study aims to answer are: * Does IV amino acid treatment reduce how severe and long-lasting kidney injury is in the first week after heart surgery? * Does IV amino acid treatment reduce signs of damage to the kidney's cells, measured in urine samples? * Researchers will compare children who receive the amino acid solution with children who receive a placebo (Lactated Ringer's, a standard IV fluid that does not contain amino acids). Neither the families nor the medical team will know which solution a child receives. About 270 children younger than 18 years undergoing certain higher-risk heart surgeries will take part at three hospitals: Cincinnati Children's Hospital Medical Center, UPMC Children's Hospital of Pittsburgh, and Nationwide Children's Hospital. Participants will: * Be assigned by chance (like flipping a coin) to receive either the amino acid solution or the placebo * Receive the study solution through an IV for 72 hours, starting in the operating room * Have routine blood tests during the first week after surgery to check kidney function * Give urine samples before surgery, 6 to 12 hours after surgery, and on the first and second days after surgery * Have their health followed for 90 days after surgery, including kidney function, time on a breathing machine, and time in the hospital.

COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)

The goal of this clinical trial is to learn whether different ways of providing information and follow-up support after acute kidney injury, also called AKI, can improve care transitions for adults being discharged from the hospital. AKI is a sudden decrease in kidney function that can occur during a hospital stay. The main questions this study aims to answer are: * Does an AKI discharge summary template improve communication about AKI after hospital discharge? * Does a chat-based educational messaging program improve patient understanding of AKI and support follow-up care after hospital discharge? * Researchers will compare usual care, an AKI discharge summary template, a chat-based educational messaging program, and the combination of the discharge summary template plus chat-based messaging. Researchers will compare four groups: * Usual care * An AKI discharge summary template * A chat-based educational messaging program * Both the AKI discharge summary template and the chat-based educational messaging program Participants will complete questionnaires at the start of the study and about 4 weeks after hospital discharge. Participants will also receive a brief phone call about 3 months after discharge, and the research team will review their medical record for information about follow-up care, lab testing, emergency department visits, and hospital readmissions.

Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery

This multicenter pilot randomized controlled trial will evaluate whether providing treating physicians with a structured hemodynamic assessment influences care after cardiac surgery. The assessment combines point-of-care ultrasound, including the Venous Excess UltraSound (VExUS) score to assess fluid tolerance, with monitoring using the Swan-Ganz IQ catheter and HemoSphere Alta system to assess fluid responsiveness. Participants will be randomized to a structured hemodynamic assessment strategy or standard care. In the intervention group, treating physicians will receive a report of the structured assessment findings upon admission to the intensive care unit and on postoperative day 1. The co-primary objectives are to evaluate the impact of the structured assessment on treating physicians' management plans and to assess the feasibility of completing the study procedures and delivering assessment reports within the predefined time frame. Secondary and exploratory objectives include evaluating fluid balance, diuretic use, inotropic support, inhaled pulmonary vasodilator use, kidney function, and postoperative clinical outcomes. Exploratory analyses will also examine ultrasound measures of fluid responsiveness in relation to Swan-Ganz IQ measurements and the relationship between right ventricular pressure patterns and venous congestion.

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.

The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)

The VPT Safety Trial (VPS) compares two common antibiotic combinations to see how they affect the kidneys of patients in the hospital with serious infections. Both combinations are approved by the Food and Drug Administration (FDA). The goal is to help doctors know which combination is safer so they can make better choices for their patients.

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