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Clinical Trials/NCT03856723
NCT03856723
Recruiting
Not Applicable

Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of REnal Replacement Therapy (POCKET)

Shanghai Zhongshan Hospital1 site in 1 country1,200 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Shanghai Zhongshan Hospital
Enrollment
1200
Locations
1
Primary Endpoint
28-day mortality
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study was to verify the prognostic value of functional kidney biomarkers on survival and renal function recovery in cardiac surgery patients with acute kidney injury.

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. Few biomarkers were validated as outcome-specific biomarkers in patients developing AKI after cardiac surgery at initiation of RRT. This study was designed to not only verify the prognostic value of functional kidney biomarkers on survival, but also predict it severity in order to optimize clinical decision making with respect to dialysis initiation and discontinuation.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
December 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing cardiac surgery who required renal replacement therapy.

Exclusion Criteria

  • History of End Stage Renal Disease or on Dialysis
  • prior kidney transplantation
  • patients with a DNR order or "do not escalate care" order

Outcomes

Primary Outcomes

28-day mortality

Time Frame: 28 days

Death from any cause at 28 days

Dependence on renal-replacement therapy at 28 days in survivors

Time Frame: 28 days

Dependence on renal-replacement therapy was defined as surviving dependent on RRT

Secondary Outcomes

  • Length of stay in the ICU(Up to 90 days or ICU discharge)
  • Length of stay in the hospital(Up to 90 days or hospital discharge)
  • Adverse events(Up to 90 days)
  • the number of days free of renal-replacement therapy, mechanical ventilation at 28 days(28 days)
  • 60- and 90-day mortality(Up to 60 or 90 days)

Study Sites (1)

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