Recruiting

Observational Study

Sponsor:

University of Saskatchewan

Code:

NCT04387149

Conditions

Novel Biomarkers of Acute Kidney Injury Following Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Acute kidney injury occurs in up to 30% of patients undergoing cardiac surgery. Cardiac surgery associated-acute kidney injury (CSA-AKI) is characterized by a sudden and sustained decrease in renal function with insufficient elimination waste products. The problem is that postoperative diagnosis of CSA-AKI is delayed because it relies solely upon the slow and unreliable rise in serum creatinine (SCr) levels that may lead to delayed start in treatment and increased risk of adverse outcomes. We hypothesize that Matrix Metalloproteins (MMPs) -2, -9 and Neutrophil gelatinase-associated lipocalin (NGAL) are associated with and earlier detectors of CSA-AKI compared to levels of SCr.

Conditions

Novel Biomarkers of Acute Kidney Injury Following Cardiac Surgery

Study ID

NCT04387149

Start date

Jan 6, 2020

Status verified date

May, 2020

Completion date

Feb, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The inclusion criteria consisted of both sexes, 18-85 years of age, undergoing elective or urgent cardiac surgery with a hemoglobin (Hgb) >100 g/L.

Exclusion Criteria:

  • The exclusion criteria included were patients for emergent surgery, pre-existing chronic kidney disease (eGFR<30 mL/min) on dialysis or prescribed nephrotoxic mediations.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

CSA-AKI

Patients that developed cardiac surgery-associated Acute Kidney Injury

non CSA-AKI

Patients that did not developed cardiac surgery-associated Acute Kidney Injury

Primary outcome measure

  • Increased MMP-2 and -9 in patients that develop CSA-AKI [ Time Frame: Pre-CPB, 10 min post-CPB time point, 4 hours post-CPD ]

Central Contacts and Locations

Central contacts

Erick D McNair, PhD

306 966-7637erick.mcnair@usask.ca

Mike Moser, MD

306 655-5320mike.moser@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Erick D McNair, PhD

306 966-7637erick.mcnair@usask.ca

Mike Moser, MD

306 655-5320mike.moser@usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

May 13, 2020

Last verified

May, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2020-05-13.