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Clinical Trials/NCT04387149
NCT04387149
Unknown
Not Applicable

Biomarkers of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery-supported Cardiac Surgery

University of Saskatchewan1 site in 1 country400 target enrollmentJanuary 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Novel Biomarkers of Acute Kidney Injury Following Cardiac Surgery
Sponsor
University of Saskatchewan
Enrollment
400
Locations
1
Primary Endpoint
Increased MMP-2 and -9 in patients that develop CSA-AKI
Last Updated
5 years ago

Overview

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.

Detailed Description

Cardiopulmonary bypass (CPB), although essential to the performance of most cardiac operations, has been shown to cause injury to other organs, particularly to the kidneys and brain. Matrix Metalloproteins (MMPs) are ubiquitous proteolytic enzymes that degrade extracellular matrix and have been shown to be involved in injury to transplant kidneys. To date, no interventions are available to decrease the risk of cardiac surgery associated-acute kidney injury (CSA-AKI). NGAL is a known indicator of injury to kidney, thus making it a promising biomarker for CSA-AKI. It may be that a single biomarker will not be sensitive and specific across the spectrum of CSA-AKI. This research investigates MMP-2, -9 and Neutrophil gelatinase-associated lipocalin (NGAL) and their association with and earlier detection of CSA-AKI compared to levels of SCr. We hypothesize that increased activity of MMPs are associated with CSA-AKI. Furthermore, MMP-2 and/ or -9 may be predictors and/ or biomarkers for the early detection of CSA-AKI compared to serum levels of creatinine.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
February 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erick McNair

Research Scientist

University of Saskatchewan

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Increased MMP-2 and -9 activity in serum and or urine in patients that develop CSA-AKI

Secondary Outcomes

  • Increased NGAL levels in patients that develop CSA-AKI(Pre-CPB, 10 min post-CPB time point, 4 hours post-CPD)

Study Sites (1)

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