NCT04293744

Acute Kidney Injury After Cardiac Surgery

Acute Kidney Injury After Cardiac Surgery; A Prospective Randomized Study of Dextran Based and Crystalloid Priming Solutions (PRIMING II Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: XVIVO Perfusion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgical Procedures
• Extracorporeal Circulation; Complications
• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	Colloid priming solution for ECC circuit	Prospective, multi-center, double-blinded, randomized, controlled clinical trial
DEVICE	Standard priming solution for ECC circuit	Prospective, multi-center, double-blinded, randomized, controlled clinical trial

Timeline

• Start date: 2020-09-04
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2020-03-03
• Last updated: 2023-12-06

Locations

1 site across 1 country: Sweden