Status:
TERMINATED
Acute Kidney Injury After Cardiac Surgery
Lead Sponsor:
XVIVO Perfusion
Conditions:
Cardiac Surgical Procedures
Extracorporeal Circulation; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
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 Pri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04293744
Start Date
September 4 2020
End Date
October 31 2023
Last Update
December 6 2023
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41251