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

May 30, 2022 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days
Death from any cause at 28 days
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
60- and 90-day mortality
Time Frame: Up to 60 or 90 days
Death from any cause at 60- and 90-days
Up to 60 or 90 days
Length of stay in the ICU
Time Frame: Up to 90 days or ICU discharge
the length of stay in the ICU
Up to 90 days or ICU discharge
Length of stay in the hospital
Time Frame: Up to 90 days or hospital discharge
the length of stay in the hospital
Up to 90 days or hospital discharge
Adverse events
Time Frame: 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
Up to 90 days
the number of days free of renal-replacement therapy, mechanical ventilation at 28 days
Time Frame: 28 days
the number of days free of renal-replacement therapy, mechanical ventilation at 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Chair: Zhe Luo, PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 23, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POCKET

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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