Tissue Inhibitor of Metalloproteinases 2 Level in Patient... | NCT06871826

Studies
Tissue Inhibitor of Metalloproteinases 2 Level in Patients Undergoing Cardiac Surgery

NCT06871826

Sponsor

Wuhan University

Status

Completed

Last Update Posted

Mar 12, 2025Actual

Enrollment

100Actual

Phase

Phase 1Phase 2

Conditions

Acute Kidney Injury
Extracorporeal Circulation; Complications
Surgery

Interventions

TIMP2 level

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2023Actual

Primary Completion Date

Jan 25, 2025Actual

Completion Date

Jan 25, 2025Actual

First Submitted Date

Mar 7, 2025

First Submission Date that Met QC Criteria

Mar 7, 2025

First Posted Date

Mar 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2025

Last Update Posted Date

Mar 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiahao Zhang, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Zhongnan HospitalPrincipal Investigator

Lead Sponsor

Wuhan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIMP2 Tertile 1	Experimental	Other: TIMP2 level	Drug: TIMP2 level
TIMP2 Tertile 2	Experimental	Other: TIMP2 level	Drug: TIMP2 level
TIMP2 Tertile 3	Experimental	Other: TIMP2 level	Drug: TIMP2 level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TIMP2 level	Drug	different TIMP2 level after on-pump cardiac surgery	TIMP2 Tertile 1 TIMP2 Tertile 2 TIMP2 Tertile 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
AKI severity	AKI stage 1，stage 2，stage 3	1 Week
need for RRT	Reflect kidney function	1 Week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongnan Hospital		Wuhan	Hubei	430061	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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Browse Branches

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