Heart Valve DiseaseNCT01023152
Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
A study testing Automated cuff-inflator in people with Heart Valve Disease, run by Yonsei University.
Trial summary
The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Automated cuff-inflator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing complex valve surgery.
Who cannot join
- older than 80 years
- those with left main disease >50%, or hepatic or pulmonary disease
- active infective endocarditis
- left ventricular ejection fraction <30%
- myocardial infarction (MI) within 3 weeks
- pre-existing renal dysfunction (serum creatinine (Cr) level >1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.
About this study
The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.
Read the detailed description
Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.
- Conditions
- Heart Valve Disease
- Being tested
- Automated cuff-inflator
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated cuff-inflatorProcedure or surgery
RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.
| Study group | Role | What they receive |
|---|---|---|
| Automated cuff-inflator | Experimental | Not described Receives: Procedure: Automated cuff-inflator |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023152
- Sponsor's protocol ID
- 4-2008-0423
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01023152
- Acronym / sponsor ID
- 4-2008-0423
- Conditions
- Heart Valve Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- First posted
- 2 Dec 2009 (estimated)
- 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.
The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.
Detailed description
Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated cuff-inflator | Experimental | Procedure: Automated cuff-inflator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing complex valve surgery.
Key exclusion criteria (6 listed)
- older than 80 years
- those with left main disease >50%, or hepatic or pulmonary disease
- active infective endocarditis
- left ventricular ejection fraction <30%
- myocardial infarction (MI) within 3 weeks
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 |
|---|---|---|
| Automated cuff-inflatorRIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated. | Procedure or surgery | Automated cuff-inflator |
Primary outcome
Not reported in the source record.
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 2 Dec 2009.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Automated cuff-inflator in people with Heart Valve Disease, run by Yonsei University.
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 1 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 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 2 Dec 2009.