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Clinical Trials/NCT04962412
NCT04962412
Completed
Not Applicable

Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

Guowei Tu1 site in 1 country3,152 target enrollmentMay 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Guowei Tu
Enrollment
3152
Locations
1
Primary Endpoint
AKI progression
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Detailed Description

Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Registry
clinicaltrials.gov
Start Date
May 12, 2021
End Date
May 31, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guowei Tu
Responsible Party
Sponsor Investigator
Principal Investigator

Guowei Tu

Scientific Secretary for Department of Critical Care Medcine

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing cardiac surgery were prospectively screened, and those who developed AKI within 48 hours post-surgery were included in the study.

Exclusion Criteria

  • History of End Stage Renal Disease or on Dialysis;
  • prior kidney transplantation;
  • patients with a DNR order;
  • patients without written informed consent;
  • pregnancy;
  • moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)

Outcomes

Primary Outcomes

AKI progression

Time Frame: 7 days

worsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3). Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for \>3 consecutive days) were classified as having AKI progression. If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.

Secondary Outcomes

  • AKI occurrence at 7 days(7 days)
  • Persistent AKI(90 days)
  • Mortality(365 days)
  • AKI progression to stage 3(7 days)
  • AKI occurrence at 3 days(3 days)
  • Length of stay in the ICU(90 days)
  • Receipt of renal replacement treatment(365 days)
  • Major adverse kidney events(365 days)
  • Persist severe AKI(90 days)
  • Length of stay in the hospital(90 days)

Study Sites (1)

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