- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristina Welinder
- Phone Number: +4676-1750562
- Email: kristina.welinder@xvivogroup.com
Study Contact Backup
- Name: Sofia Jonhede
- Phone Number: +46763286731
- Email: sofia.jonhede@xvivogroup.com
Study Locations
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Västra Götalands Län
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Gothenburg, Västra Götalands Län, Sweden, 41251
- Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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Prospective, multi-center, double-blinded, randomized, controlled clinical trial
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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).
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Prospective, multi-center, double-blinded, randomized, controlled clinical trial
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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
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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)
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Within 96 hours after ICU arrival
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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.
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NAG-excretion (U-NAG/U-creatinine)
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1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.
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eGFR
Time Frame: Pre-operative and within 96 hours after ICU arrival
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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
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Pre-operative and within 96 hours after ICU arrival
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Incidence of AKI
Time Frame: Within 96 hours after ICU arrival
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Incidence of AKI of different stages according to the KDIGO creatinine criteria
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Within 96 hours after ICU arrival
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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.
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Hemolysis measured as free hemoglobin (PfHb)
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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.
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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.
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Measured concentrations of CNS injury markers Tau, NFL, NSE, and S100B
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Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
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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.
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Measured concentrations of myocardial injury markers TnI or TnT.
TnI or TnT is chosen according to institutional standard
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Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative bleeding
Time Frame: The first 24 hours after disconnection from ECC
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Drain losses
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The first 24 hours after disconnection from ECC
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Post-operative transfusions and use of hemostatic agents
Time Frame: The first 24 hours after disconnection from ECC
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Total transfusions and/or use of erythrocytes, plasma, thrombocytes, hemostatic pharmaceuticals
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The first 24 hours after disconnection from ECC
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lukas Lannemyr, MD,PhD, Sahlgrenska University Hospital, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Priming II Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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