Tissue Inhibitor of Metalloproteinases 2 Level in Patients Undergoing Cardiac Surgery

March 7, 2025 updated by: Jiahao Zhang, Wuhan University

Tissue Inhibitor of Metalloproteinases 2 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery

Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Tissue Inhibitor of Metalloproteinases 2 (TIMP2) is associated with ischemia-reperfusion injury. In this study, relationship between TIMP2 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of TIMP2 for early prediction of CSA-AKI was further evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430061
        • Zhongnan Hospital

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

Description

Inclusion Criteria:

  • Patients (≥18 years old) underwent on-pump cardiac surgery
  • admitted to ICU immediately after surgery

Exclusion Criteria:

  • Patients younger than 18 years
  • with prior AKI
  • end-stage kidney disease
  • need for chronic hemodialysis
  • pregnant patients
  • unable to give written consent for participation

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIMP2 Tertile 1
Other: TIMP2 level
Drug: TIMP2 level
different TIMP2 level after on-pump cardiac surgery
Experimental: TIMP2 Tertile 2
Other: TIMP2 level
Drug: TIMP2 level
different TIMP2 level after on-pump cardiac surgery
Experimental: TIMP2 Tertile 3
Other: TIMP2 level
Drug: TIMP2 level
different TIMP2 level after on-pump cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the development of CSA-AKI
Time Frame: 1 Week
the development of CSA-AKI
1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI severity
Time Frame: 1 Week
AKI stage 1，stage 2，stage 3
1 Week
need for RRT
Time Frame: 1 Week
Reflect kidney function
1 Week
duration of AKI (≥7 days)
Time Frame: 1 Week
Reflect kidney function
1 Week
length of ICU stay
Time Frame: up to 28 days
Reflect patient prognosis
up to 28 days
post-operative hospital stay
Time Frame: up to 28 days
Reflect patient prognosis
up to 28 days

Collaborators and Investigators

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

Sponsor

Wuhan 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)

July 22, 2023

Primary Completion (Actual)

January 25, 2025

Study Completion (Actual)

January 25, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202123306

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

product manufactured in and exported from the U.S.

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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