Acute Kidney Injury After Cardiac Surgery

NCT04293744 | Terminated

• 1 other identifier: Priming II Trial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Colloid priming solution; Cardiopulmonary bypass; Extracorporeal circulation; ECC; Acute Kidney Injury; AKI

Outcome Measures

Primary Outcomes (1)

• Incidence of post-operative AKI

  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)

  Within 96 hours after ICU arrival

Secondary Outcomes (6)

• NAG excretion

  1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.

• eGFR

  Pre-operative and within 96 hours after ICU arrival

• Incidence of AKI

  Within 96 hours after ICU arrival

• 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.

• CNS injury markers

  Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.

Other Outcomes (2)

• Post-operative bleeding

  The first 24 hours after disconnection from ECC

• Post-operative transfusions and use of hemostatic agents

  The first 24 hours after disconnection from ECC

Study Arms (2)

Colloid priming solution for ECC circuit

EXPERIMENTAL

Priming of ECC circuit with approximately 1200 mL PrimECC.

Device: Colloid priming solution for ECC circuit

Standard priming solution for ECC circuit

ACTIVE COMPARATOR

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).

Device: Standard priming solution for ECC circuit

Interventions

Colloid priming solution for ECC circuit DEVICE

Prospective, multi-center, double-blinded, randomized, controlled clinical trial

Colloid priming solution for ECC circuit

Standard priming solution for ECC circuit DEVICE

Prospective, multi-center, double-blinded, randomized, controlled clinical trial

Standard priming solution for ECC circuit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/

You may not qualify if:

• 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

Sponsors & Collaborators

• XVIVO Perfusion: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41251, Sweden

Location

Related Publications (1)

• Juvakka O, Wallinder A, Moller-Sorensen PH, Matschke K, Jeppsson A, Lannemyr L. Dextran vs. Crystalloid Priming Solution in Cardiac Surgery: A Randomized Trial on Acute Kidney Injury. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70139. doi: 10.1111/aas.70139.

  PMID: 41144782 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lukas Lannemyr, MD,PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: March 3, 2020
• Study Start: September 4, 2020
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)