CClinicalTrials.gg
CompletedNCT06871826Updated Mar 12, 2025

Tissue Inhibitor of Metalloproteinases 2 Level in Patients Undergoing Cardiac Surgery

A Phase 1/2 interventional study of TIMP2 level in Acute Kidney Injury, Extracorporeal Circulation; Complications and Surgery, sponsored by Wuhan University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Wuhan University · Phase 1/2, Interventional, and Other

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jul 2023, registered Mar 2025).
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Kidney Injury
  • Extracorporeal Circulation; Complications
  • Surgery

Browse trials for

03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Wuhan University is the lead sponsor of 45 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    TIMP2 Tertile 1

    Other: TIMP2 level

    Drug: TIMP2 level

  • Experimental
    TIMP2 Tertile 2

    Other: TIMP2 level

    Drug: TIMP2 level

  • Experimental
    TIMP2 Tertile 3

    Other: TIMP2 level

    Drug: TIMP2 level

Interventions

  • DrugTIMP2 level

    different TIMP2 level after on-pump cardiac surgery

06

What researchers measure

Primary outcomes

  1. the development of CSA-AKI

    the development of CSA-AKI

    Time frame: 1 Week

Secondary outcomes

  1. AKI severity

    AKI stage 1,stage 2,stage 3

    Time frame: 1 Week

  2. need for RRT

    Reflect kidney function

    Time frame: 1 Week

  3. duration of AKI (≥7 days)

    Reflect kidney function

    Time frame: 1 Week

  4. length of ICU stay

    Reflect patient prognosis

    Time frame: up to 28 days

  5. post-operative hospital stay

    Reflect patient prognosis

    Time frame: up to 28 days

07

Study locations

1 site
  • Zhongnan Hospital
    Wuhan, Hubei 430061, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06871826
Lead sponsor
Wuhan University
Responsible party
Jiahao Zhang (Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Zhongnan Hospital) — Principal investigator
First posted
Mar 12, 2025
Start date
Jul 22, 2023
Primary completion
Jan 25, 2025
Completion
Jan 25, 2025
Last update
Mar 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion