Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
100 participants
INTERVENTIONAL
2020-09-04
2023-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Colloid priming solution for ECC circuit
Priming of ECC circuit with approximately 1200 mL PrimECC.
Colloid priming solution for ECC circuit
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
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).
Standard priming solution for ECC circuit
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
Interventions
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Colloid priming solution for ECC circuit
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
Standard priming solution for ECC circuit
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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XVIVO Perfusion
INDUSTRY
Responsible Party
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Principal Investigators
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Lukas Lannemyr, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Countries
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References
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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.
Other Identifiers
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Priming II Trial
Identifier Type: -
Identifier Source: org_study_id