Acute Kidney InjuryPhase 1/2NCT06871826
Tissue Inhibitor of Metalloproteinases 2 Level in Patients Undergoing Cardiac Surgery
A Phase 1/2 study testing TIMP2 level in people with Acute Kidney Injury and Extracorporeal Circulation; Complications, run by Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Extracorporeal Circulation; Complications, Surgery
- What is being tested?
- TIMP2 level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2023to 25 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (≥18 years old) underwent on-pump cardiac surgery
- admitted to ICU immediately after surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- TIMP2 level
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIMP2 levelDrug
different TIMP2 level after on-pump cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| TIMP2 Tertile 1 | Experimental | Other: TIMP2 level Receives: Drug: TIMP2 level |
| TIMP2 Tertile 2 | Experimental | Other: TIMP2 level Receives: Drug: TIMP2 level |
| TIMP2 Tertile 3 | Experimental | Other: TIMP2 level Receives: Drug: TIMP2 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
the development of CSA-AKI
the development of CSA-AKI
Measured: 1 Week
Secondary outcomes (5)
AKI severity
AKI stage 1，stage 2，stage 3
Measured: 1 Week
need for RRT
Reflect kidney function
Measured: 1 Week
duration of AKI (≥7 days)
Reflect kidney function
Measured: 1 Week
length of ICU stay
Reflect patient prognosis
Measured: up to 28 days
post-operative hospital stay
Reflect patient prognosis
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start22 Jul 2023
- Primary completion25 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- TIMP2 level
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiahao Zhang, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871826
- Sponsor's protocol ID
- 202123306
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Inhibitor of Metalloproteinases 2 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06871826
- Acronym / sponsor ID
- 202123306
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- TIMP2 level
| Arm | Type | Receives |
|---|---|---|
| TIMP2 Tertile 1 | Experimental | Drug: TIMP2 levelOther: TIMP2 level |
| TIMP2 Tertile 2 | Experimental | Drug: TIMP2 levelOther: TIMP2 level |
| TIMP2 Tertile 3 | Experimental | Drug: TIMP2 levelOther: TIMP2 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (≥18 years old) underwent on-pump cardiac surgery
- admitted to ICU immediately after surgery
Key exclusion criteria (6 listed)
- Patients younger than 18 years
- with prior AKI
- end-stage kidney disease
- need for chronic hemodialysis
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIMP2 leveldifferent TIMP2 level after on-pump cardiac surgery | Drug | TIMP2 Tertile 1, TIMP2 Tertile 2, TIMP2 Tertile 3 |
Primary outcome
the development of CSA-AKI
Time frame: 1 Week
the development of CSA-AKI
5 secondary outcomes
AKI severity
Time frame: 1 Week
need for RRT
Time frame: 1 Week
duration of AKI (≥7 days)
Time frame: 1 Week
length of ICU stay
Time frame: up to 28 days
post-operative hospital stay
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TIMP2 level in people with Acute Kidney Injury and Extracorporeal Circulation; Complications, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the development of CSA-AKI (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.