Acute Kidney Injury After Cardiac Surgery

Status Terminated

Clinical Trial Summary

PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1. In a previous RCT comparing PrimECC with crystalloid priming fluid, patients in the PrimECC group experienced less hemolysis, less tubular cell injury and beneficial effect on the fluid balance. This study will investigate if, in a population at high risk of acute kidney injury (AKI), priming the ECC circuit with PrimECC instead of crystalloid solution will lead to a reduction of postoperative AKI. The hypothesis is that PrimECC, compared to crystalloid prime, will reduce postoperative AKI. The study is a Swedish multicenter, double-blinded, randomized, controlled clinical trial. The trial will include 366 patients aged ≥18 years, scheduled for cardiac surgery with cardiopulmonary bypass, with an "Acute kidney injury risk score" ≥30% according to Birnie et al. (2014). The primary outcome of the study is the incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 h or ≥ 50 % increase from baseline) within 96 hours after arrival to the ICU. Secondary outcomes are between-group differences in hemolysis, tubular cell injury (NAG-excretion), estimated GFR, and incidence of AKI of different stages according to the KDIGO creatinine criteria. In addition, differences in CNS (Tau, NFL, NSE, and S100B) and cardiac (TNT/TNI) injury markers will be investigated.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acute Kidney Injury
Cardiac Surgical Procedures
Extracorporeal Circulation; Complications
Wounds and Injuries

Clinical Trial Details

NCT number	NCT04293744
Study type	Interventional
Source	XVIVO Perfusion
Contact
Status	Terminated
Phase	N/A
Start date	September 4, 2020
Completion date	October 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05538351` - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03938038` - Guidance of Ultrasound in Intensive Care to Direct Euvolemia	N/A
Recruiting	`NCT05805709` - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial	N/A
Recruiting	`NCT05318196` - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting	`NCT05897840` - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients	N/A
Recruiting	`NCT04986137` - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Completed	`NCT04095143` - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting	`NCT06026592` - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting	`NCT06064305` - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated	`NCT03438877` - Intensive Versus Regular Dosage For PD In AKI.	N/A
Terminated	`NCT03305549` - Recovery After Dialysis-Requiring Acute Kidney Injury	N/A
Completed	`NCT05990660` - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery	N/A
Completed	`NCT04062994` - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated	`NCT02860130` - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)	Phase 3
Completed	`NCT06000098` - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting	`NCT05548725` - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed	`NCT02665377` - Prevention of Akute Kidney Injury, Hearttransplant, ANP	Phase 3
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A
Recruiting	`NCT04523064` - iSGLT2 in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump	Phase 4