Acute Kidney Injury After Cardiac Surgery

Not Applicable

Terminated

• Conditions: Cardiac Surgical Procedures; Extracorporeal Circulation; Complications; Acute Kidney Injury
• Interventions: Device: Standard priming solution for ECC circuit; Device: Colloid priming solution for ECC circuit

• Registration Number: NCT04293744
• Lead Sponsor: XVIVO Perfusion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-03-01
• Study First Posted: 2020-03-03
• Study Start: 2020-09-04
• Primary Completion: 2023-08-31
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard priming solution for ECC circuit	Standard priming solution for ECC circuit	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).
Colloid priming solution for ECC circuit	Colloid priming solution for ECC circuit	Priming of ECC circuit with approximately 1200 mL PrimECC.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative AKI	Within 96 hours after ICU arrival	Incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 hours or ≥ 50 % increase from baseline)

Secondary Outcome Measures

Name	Time	Method
eGFR	Pre-operative and within 96 hours after ICU arrival	pre-operative (day before surgery) compared to the highest post-operative value Measured value of pre-operative eGFR compared to the highest post-operative value within 96 hours after ICU arrival, calculated using the CKD-EPI formula
Hemolysis	Pre-operative (after induction of anesthesia) and at 1 hour post initiation of ECC, 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.	Hemolysis measured as free hemoglobin (PfHb)
NAG excretion	1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.	NAG-excretion (U-NAG/U-creatinine)
Incidence of AKI	Within 96 hours after ICU arrival	Incidence of AKI of different stages according to the KDIGO creatinine criteria
CNS injury markers	Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.	Measured concentrations of CNS injury markers Tau, NFL, NSE, and S100B
Myocardial injury markers	Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC.	Measured concentrations of myocardial injury markers TnI or TnT. TnI or TnT is chosen according to institutional standard

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götalands Län, Sweden