Acute Kidney Injury After Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04293744
• Other study ID #: Priming II Trial
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: XVIVO Perfusion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-calcula tor/

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgical Procedures
• Extracorporeal Circulation; Complications
• Wounds and Injuries

Intervention

Device:
• 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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götalands Län

Sponsors (1)

Lead Sponsor	Collaborator
XVIVO Perfusion

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative bleeding	Drain losses	The first 24 hours after disconnection from ECC
Other	Post-operative transfusions and use of hemostatic agents	Total transfusions and/or use of erythrocytes, plasma, thrombocytes, hemostatic pharmaceuticals	The first 24 hours after disconnection from ECC
Primary	Incidence of post-operative AKI	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	NAG excretion	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.
Secondary	eGFR	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
Secondary	Incidence of AKI	Incidence of AKI of different stages according to the KDIGO creatinine criteria	Within 96 hours after ICU arrival
Secondary	Hemolysis	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.
Secondary	CNS injury markers	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.
Secondary	Myocardial injury markers	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.