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Completed

NCT Number: NCT06871826

Tissue Inhibitor of Metalloproteinases 2 Level 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.

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Key information

Conditions

Acute Kidney Injury Extracorporeal Circulation; Complications Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Surgery Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhongnan Hospital

Wuhan, Hubei, 430061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIMP2 level

Drug

different TIMP2 level after on-pump cardiac surgery

Primary outcomes

  1. the development of CSA-AKI

    Time frame: 1 Week

    the development of CSA-AKI

Secondary outcomes

  1. AKI severity

    Time frame: 1 Week

    AKI stage 1，stage 2，stage 3

  2. need for RRT

    Time frame: 1 Week

    Reflect kidney function

  3. duration of AKI (≥7 days)

    Time frame: 1 Week

    Reflect kidney function

  4. length of ICU stay

    Time frame: up to 28 days

    Reflect patient prognosis

  5. post-operative hospital stay

    Time frame: up to 28 days

    Reflect patient prognosis

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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