Clinical Research Directory

Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury

Sepsis-associated acute kidney injury (SA-AKI) is common in critically ill patients and often requires continuous kidney replacement therapy (CRRT). The choice of blood thinner (anticoagulation) during CRRT affects how long the filter works and the risk of bleeding. Citrate is the current standard blood thinner, but it can cause metabolic problems in patients with shock or liver dysfunction. Nafamostat mesylate (NM) is a newer alternative with a very short half-life and local action, which may offer both effectiveness and safety. However, no large, high-quality study has directly compared NM with citrate in SA-AKI patients. This study aims to show that NM is not worse than citrate for a key outcome called MAKE30 (a combination of death, continued need for kidney replacement therapy, or persistent kidney dysfunction at 30 days). We will also compare filter life, kidney recovery, death rates, hospital stay, bleeding events, and other outcomes. This is a multicenter, randomized, single-blind, non-inferiority trial. A total of 1162 patients will be assigned equally to receive either NM or citrate during CRRT. Patients will not know which treatment they get, but healthcare providers will know. The study includes adults aged 18-90 with sepsis and severe acute kidney injury requiring CRRT for more than 48 hours, who have given informed consent. Key exclusions include active bleeding risk, severe liver failure, pregnancy, or participation in another trial within 3 months. The main outcome is MAKE30 at 30 days. Secondary outcomes include filter life, days off CRRT, death rates, length of stay, bleeding, and changes in organ failure scores. Safety monitoring will focus on metabolic problems and citrate accumulation. The study is designed to test whether NM is non-inferior to citrate with a margin of 5%. If non-inferiority is shown, we will also test if NM is superior. Analyses will follow intention-to-treat principles.

Validation of a Regional Citrate Anticoagulation Protocol in Critically Ill Patients on Continuous Renal Replacement Therapy

The objective of this study is to evaluate the effectiveness of a modified continuous renal replacement therapy (CRRT) protocol in maintaining electrolyte balance in adult patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU). The study assesses whether the use of continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under citrate anticoagulation reduces electrolyte losses and the need for electrolyte supplementation compared with standard dialytic CRRT. Participants receiving standard CRRT will be compared with those treated with the modified protocol. The duration of participation corresponds to the period during which CRRT is required. Data collection will cease once CRRT is discontinued.

Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)

This is a single-center, randomized, open-label, parallel-controlled clinical trial designed to investigate the anticoagulation efficacy and safety of different initial doses of Nafamostat Mesilate (NM) in ICU patients undergoing Continuous Renal Replacement Therapy (CRRT). Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital, Southern Medical University, to identify eligible participants based on inclusion and exclusion criteria. After obtaining informed consent, participants will be randomized into two groups. On the basis of standardized CRRT treatment, the Low-Dose Group (Group A) will receive a continuous infusion of Nafamostat Mesilate at an initial dose of 20 mg/h, while the High-Dose Group (Group B) will receive an initial dose of 50 mg/h. The drug will be continuously infused pre-filter into the CRRT circuit. Dosage adjustments will be made for both groups to maintain target anticoagulation levels while ensuring that pre-filter safety limits are not exceeded. The primary outcome measure is filter lifespan, along with other secondary outcomes.

Prospective Analysis of Arteriovenous Access (AVA) Use for Continuous Renal Replacement Therapy (CRRT)

Arteriovenous fistula or graft are the ideal hemodialysis access. Nonetheless the most common access type used for Continuous Renal Replacement Therapy (CRRT) is either a temporary or permanent hemodialysis catheter. Recommendations for the use of catheters to deliver CRRT in end stage kidney disease (ESKD) patients are lacking on data and subjective to anecdotal experiences and expert consensus. The repetitive placement of catheters in ESKD patients have shown to increase the chances of central vascular stenosis which is one of the main risk factors that lead to access failure. Also, the repetitive use of dialysis catheters increases the risk for catheter associated infections. Dedicated studies demonstrating the safety and feasibility of using arteriovenous access (AVA) for CRRT are scarce. No screening criteria or algorithm exists to determine the adequate patient and clinical scenario to use AVA for CRRT. Goals of the study: 1. To develop a standard operating procedure for the use of AVA in CRRT. 2. Evaluate the safety and efficacy of using AVA for CRRT.

Insights Into the Continuous Renal Replacement Therapy to Critical Ill Patients

This is a multinational, prospective, observational study designed to characterize patient demographics, prescription parameters, and process measures of continuous renal replacement therapy (CRRT) in intensive care units (ICUs) worldwide. The study aims to examine similarities and differences in CRRT practices and outcomes among critically ill adult patients across a global network of medical centers. The goal is to develop a large, comprehensive repository of data on CRRT practices and outcomes. This repository will enable characterization of variation in standard CRRT practices across medical centers. Natural variability in practice patterns-both between and within centers-will provide an opportunity to compare outcomes associated with different approaches and to generate high-quality preliminary data to inform future interventional trials. Primary Objective \- To describe global patient characteristics, CRRT modalities, and clinical outcomes among patients receiving CRRT. Secondary Objectives * To compare clinical outcomes across geographic regions and CRRT modalities. * To identify patient-level and practice-level predictors of outcomes. * To assess the impact of comorbid conditions (e.g., diabetes mellitus) on CRRT outcomes. Exploratory Objectives * To evaluate long-term renal outcomes and patient-reported quality of life. * To explore health economics and resource utilization related to CRRT. Study Population All patients receiving CRRT as part of routine clinical care in the ICU at participating centers will be eligible for inclusion. Data Collection The study will support an epidemiological assessment of patients undergoing CRRT, including, but not limited to, demographics, underlying disease states, severity of illness, physiological support, indications for CRRT, and clinical outcomes. Outcomes of interest include ICU and hospital mortality, ICU and hospital length of stay, and renal recovery.

Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy

The goal of this randomised controlled trial is to compare the cumulative fluid balance over the first 72 h following inclusion guided by mVExUS versus standard of care in critically ill patients with acute kidney injury receiving CRKT . It will also compare the proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care. The main questions it aims to answer are: Does fluid removal rate guided by mVExUS will reduce cumulative fluid balance over the course of the first 72 h of CRRT in ICU patients compared to standard care Participants will: Get fluid assessment by mVExUS protocol or a strandard care every 8 hours for 72 hours

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate anticoagulation (RCA) software to facilitate citrate and calcium compensation prescription. The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH) and 2) to observe that the software and interface for the PrisMax System Version 3.x with calcium line accessory allows for implementation of regional citrate anticoagulation (RCA) (citrate and calcium dosing) during CRRT with Prismocitrate 18 and intended prescription. The study period of the patient's CRRT will be up to 10 days.

Continuous Renal Replacement Therapy Doses in Critically Ill Patients With Acute Kidney Injury

Acute kidney injury in critically ill patients admitted to the ICU is a common complication associated with high mortality or long-term chronic kidney damage. Some of these patients require continuous renal replacement therapy (low-intensity hemodialysis for 24 hours) until renal function recovery is achieved. Continuous Renal Replacement Therapy (CRRT) is a crucial treatment for ICU patients with acute renal failure. It offers continuous toxin removal and prevents fluid accumulation in the patient's body. The therapy not only eliminates toxins but also physiological substances, including micronutrients and essential elements for cellular metabolism and organ function. Currently, there is limited information available to adjust the renal therapy dose and avoid or balance the loss of these substances without causing toxin accumulation. Some studies suggest that high doses of therapy do not provide benefits and increase complications. The objective of this study is to evaluate two doses of continuous renal therapy in terms of internal environment control (sodium, potassium, and acids and bases), micronutrient loss, and toxin elimination. After 48 hours of therapy, patients will be assigned to continue with a dose equal to the initial dose or a decrease in the initial dose. These two options are part of the current standard practice in our center. Patients participating in the study will be randomly assigned one of the continuous renal therapy doses. The study is open, so treating physicians will always know the therapy the patient is receiving and can freely adjust it if deemed necessary. The intervention duration is 96 hours, after which the dose will be at the discretion of the treating medical team. A follow-up will be conducted through medical records or phone calls approximately 90 days after starting therapy. The risks for the patient are minimal, as toxin elimination monitoring will be even more intensive than usual. The study plans to include approximately 100 patients.

Ultrasound-Guided Microbubble Removal and Filter Lifespan During CRRT: A Pilot Crossover Study

What is this study about? This study is designed to evaluate whether ultrasound-guided removal of microbubbles during circuit priming in Continuous Renal Replacement Therapy (CRRT) can extend the filter lifespan for critically ill patients who require CRRT. The investigators aim to determine if this technique improves the duration of effective filter use and reduces complications related to filter clotting. Who can join? Adults (18 years or older) admitted to the Intensive Care Unit (ICU) and diagnosed with acute kidney injury (AKI) or chronic kidney failure (CKD) who require CRRT and are expected to undergo at least two sessions of CRRT treatment. Participants or their legal representatives must provide signed informed consent. Who cannot join? Patients with severe coagulation disorders, platelet count \<30×10\^9/L, contraindications to anticoagulation, significant changes in clinical scores or blood tests between CRRT sessions, or any other condition deemed unsuitable by the investigator. What will happen during the study? Two Treatment Methods: Conventional Priming (Control): The CRRT circuit will be primed following the standard visual bubble inspection protocol. Ultrasound-Guided Priming (Intervention): The circuit will be primed using real-time ultrasound to detect and remove microbubbles from key locations. Each participant will receive both interventions in random order, separated by a washout period of at least 24 hours. Safe and Routine Monitoring: Ultrasound scans will be performed on the filter and circuit to guide microbubble removal. Standardized CRRT treatment protocols, including filter type and anticoagulation regimen, will be used for all sessions. Other Data Collection: Patient information (e.g., age, sex, medical history, APACHE II score) CRRT treatment details (e.g., filter lifespan, filter clotting incidence, coagulation parameters) Monitoring of adverse events and clinical outcomes (including 28-day survival and treatment costs) What are the benefits and risks? Benefits: This study may provide evidence for a simple, non-invasive method to reduce filter clotting, improve CRRT efficiency, and enhance patient outcomes. Risks: Ultrasound monitoring is non-invasive and does not add risk beyond standard care. All procedures are standard clinical practice. Your Rights and Safety Voluntary Participation: Participation is voluntary; withdrawal is allowed at any time without affecting clinical care. Ethical Approval: The study protocol is reviewed and approved by the hospital's ethics committee. Confidentiality: All personal information and test results will be kept confidential.