Biomarkers of Acute Kidney Injury Following Cardiac Surgery

NCT ID: NCT04387149

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2022-02-28

Brief Summary

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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

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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.

Conditions

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Novel Biomarkers of Acute Kidney Injury Following Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CSA-AKI

Patients that developed cardiac surgery-associated Acute Kidney Injury

No interventions assigned to this group

non CSA-AKI

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Erick McNair

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erick D McNair, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Erick D McNair, PhD

Role: CONTACT

306 966-7637

Mike Moser, MD

Role: CONTACT

306 655-5320

Facility Contacts

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Erick D McNair, PhD

Role: primary

306 966-7637

Mike Moser, MD

Role: backup

306 655-5320

Other Identifiers

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Bio 113

Identifier Type: -

Identifier Source: org_study_id

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