Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT

Recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT03856723
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2019-02-23
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Study Start: 2019-03-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	28 days	Death from any cause at 28 days
Dependence on renal-replacement therapy at 28 days in survivors	28 days	Dependence on renal-replacement therapy was defined as surviving dependent on RRT

Secondary Outcome Measures

Name	Time	Method
Length of stay in the ICU	Up to 90 days or ICU discharge	the length of stay in the ICU
Length of stay in the hospital	Up to 90 days or hospital discharge	the length of stay in the hospital
Adverse events	Up to 90 days	with a focus on the complications potentially related to acute kidney injury or renal-replacement therapy during the first 7 days after enrollment
the number of days free of renal-replacement therapy, mechanical ventilation at 28 days	28 days	the number of days free of renal-replacement therapy, mechanical ventilation at 28 days
60- and 90-day mortality	Up to 60 or 90 days	Death from any cause at 60- and 90-days

Trial Locations

Locations (1)

Zhongshan hospital, Fudan university; 🇨🇳 Shanghai, China