Acute Kidney Injury After Cardiac Surgery

November 29, 2023 updated by: XVIVO Perfusion

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Västra Götalands Län
      • Gothenburg, Västra Götalands Län, Sweden, 41251
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colloid priming solution for ECC circuit
Priming of ECC circuit with approximately 1200 mL PrimECC.
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
Active Comparator: 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).
Prospective, multi-center, double-blinded, randomized, controlled clinical trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-operative AKI
Time Frame: 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)
Within 96 hours after ICU arrival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NAG excretion
Time Frame: 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)
1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.
eGFR
Time Frame: 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
Pre-operative and within 96 hours after ICU arrival
Incidence of AKI
Time Frame: Within 96 hours after ICU arrival
Incidence of AKI of different stages according to the KDIGO creatinine criteria
Within 96 hours after ICU arrival
Hemolysis
Time Frame: 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)
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
Time Frame: 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
Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
Myocardial injury markers
Time Frame: 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
Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative bleeding
Time Frame: The first 24 hours after disconnection from ECC
Drain losses
The first 24 hours after disconnection from ECC
Post-operative transfusions and use of hemostatic agents
Time Frame: The first 24 hours after disconnection from ECC
Total transfusions and/or use of erythrocytes, plasma, thrombocytes, hemostatic pharmaceuticals
The first 24 hours after disconnection from ECC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Lukas Lannemyr, MD,PhD, Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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