Relationship Between Postoperative Tempeartive and Acute Kidney Injury

October 16, 2024 updated by: Yonsei University

Relationship Between First 12-h Body Temperature and Acute Kidney Injury After Valvular Heart Surgery

The investigators aimed to identify body temperature trajectory classes based on core temperature changes during the first 12 hours post-surgery and to explore their relationship with postoperative acute kidney injury in patients undergoing valvular heart surgery.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3274

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

tertiary care hospital

Description

Inclusion Criteria:

  • Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System

Exclusion Criteria:

  • Patients who underwent the same surgery within 30 days,
  • Patients with less than two temperature measurements within 12 hours after surgery, - Patients with missing creatinine test values before and within seven days after surgery,
  • Patients who died during surgery

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
acute kidney injury ≥ stage 2 according to the KDIGO criteria
Time Frame: seven days after valvular heart surgery
According to the KDIGO criteria, postoperative acute kidney injury of stage 2 or higher was defined as a 100% increase in creatinine within the first seven days after surgery. The association between stage 2-3 acute kidney injury and postoperative body temperature trajectory classes was investigated.
seven days after valvular heart surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non-recovery from acute kidney injury within 48
Time Frame: 72 hours after the onset of acute kidney injury
The association between postoperative body temperature trajectory classes and non-recovery from acute kidney injury was investigated at two time points: within 48 hours
72 hours after the onset of acute kidney injury
non-recovery from acute kidney injury within 72 hours
Time Frame: 72 hours after the onset of acute kidney injury
The association between postoperative body temperature trajectory classes and non-recovery from acute kidney injury was investigated at two time points: within 72 hours.
72 hours after the onset of acute kidney injury

Collaborators and Investigators

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

Sponsor

Yonsei 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)

August 12, 2024

Primary Completion (Estimated)

August 11, 2026

Study Completion (Estimated)

August 11, 2026

Study Registration Dates

First Submitted

October 13, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2024-0771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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