Acute Kidney Injury After Cardiac Surgery

XVIVO

Status: Terminated

Conditions: Acute Kidney Injury; Extracorporeal Circulation; Complications; Cardiac Surgical Procedures

Treatments: Device: Colloid priming solution for ECC circuit; Device: Standard priming solution for ECC circuit

Study type: Interventional

Funder types: Industry

Identifiers

NCT04293744

Priming II Trial

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has signed and dated the EC approved informed consent
• Subject is ≥ 18 years of age
• Requires elective or urgent (non-emergency) cardiac procedure requiring the use of ECC.
• Preoperative "Acute kidney injury risk score" ≥30%, found at http://cardiacsurgeryleicester.com/our-research/acute-kidney-injury-risk-score-calculator/

Exclusion criteria

• Unable to give informed consent
• Known bleeding disorder
• Known intolerance or contraindication to dextran
• Acute Surgery (requires emergency cardiac procedure/surgery)
• Currently using an antithrombotic medication which has not been discontinued per institution protocol
• Malignancy; Surgery within 5 years or ongoing antitumoral treatment
• Has ongoing sepsis or endocarditis
• Requires pre-operative dialysis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Colloid priming solution for ECC circuit

Experimental group

Description:

Priming of ECC circuit with approximately 1200 mL PrimECC.

Treatment:

Device: Colloid priming solution for ECC circuit

Standard priming solution for ECC circuit

Active Comparator group

Description:

Priming of ECC circuit with approximately 1200 mL standard priming solution (crystalloid solution with or without mannitol addition as per routine of the participating clinic).

Treatment:

Device: Standard priming solution for ECC circuit