Clinical trial NCT04293744: Acute Kidney Injury After Cardiac Surgery
Official title: Acute Kidney Injury After Cardiac Surgery; A Prospective Randomized Study of Dextran Based and Crystalloid Priming Solutions (PRIMING II Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Surgical Procedures
Extracorporeal Circulation; Complications
Acute Kidney Injury
Keywords: Colloid priming solution
Cardiopulmonary bypass
Extracorporeal circulation
ECC
Acute Kidney Injury
AKI
Lead sponsor: XVIVO Perfusion
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of post-operative AKI
timeFrame: Within 96 hours after ICU arrival
Secondary outcomes:
measure: NAG excretion
timeFrame: 1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.
measure: eGFR
timeFrame: Pre-operative and within 96 hours after ICU arrival
measure: Incidence of AKI
timeFrame: Within 96 hours after ICU arrival
measure: Hemolysis
timeFrame: 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.
measure: CNS injury markers
timeFrame: Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
measure: Myocardial injury markers
timeFrame: Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC.
Other outcomes:
measure: Post-operative bleeding
timeFrame: The first 24 hours after disconnection from ECC
measure: Post-operative transfusions and use of hemostatic agents
timeFrame: The first 24 hours after disconnection from ECC
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götalands Län
Study officials:
affiliation: Sahlgrenska University Hospital
name: Lukas Lannemyr, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: