Valvular Heart Disease PatientsNCT02720549
The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery
A study testing remote ischemic postconditioning and valvular surgery with bypass in people with Valvular Heart Disease Patients, run by Yonsei University at 1 site in South Korea.
Trial summary
Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Valvular Heart Disease Patients
- What is being tested?
- remote ischemic postconditioning and valvular surgery with bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2016to 14 Apr 2017
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are undergoing valvular heart surgery
- Adult
- age 19-80
Who cannot join
- peripheral vascular disease with circulation deterioration
- Renal replacement therapy
- preconditioning medication
- Myocardiac infarction within 3 weeks
- active infective endocarditis
- high dosage steroid therapy
- mental retardation
- unlettered person
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, 120-752
About this study
Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.
- Conditions
- Valvular Heart Disease Patients
- Being tested
- remote ischemic postconditioning, valvular surgery with bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic postconditioningProcedure or surgery
Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.
valvular surgery with bypassProcedure or surgery
valvular surgery with bypass
| Study group | Role | What they receive |
|---|---|---|
| post-ischemic conditioning group | Experimental | Not described Receives: Procedure: remote ischemic postconditioning |
| valvular surgery with bypass group | Placebo comparator | Not described Receives: Procedure: valvular surgery with bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start7 Mar 2016
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart Disease PatientsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720549
- Sponsor's protocol ID
- 4-2015-1198
- Status last verified
- Jan 2019
- First submitted
- 22 Mar 2016
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Song JW, Lee WK, Lee S, Shim JK, Kim HJ, Kwak YL. Remote ischaemic conditioning for prevention of acute kidney injury after valvular heart surgery: a randomised controlled trial. Br J Anaesth. 2018 Nov;121(5):1034-1040. doi: 10.1016/j.bja.2018.07.035. Epub 2018 Sep 18.
PubMed 30336847
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT02720549
- Acronym / sponsor ID
- 4-2015-1198
- Conditions
- Valvular Heart Disease Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 28 Mar 2016 (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.
Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-ischemic conditioning group | Experimental | Procedure: remote ischemic postconditioning |
| valvular surgery with bypass group | Placebo comparator | Procedure: valvular surgery with bypass |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who are undergoing valvular heart surgery
- Adult
- age 19-80
Key exclusion criteria (8 listed)
- peripheral vascular disease with circulation deterioration
- Renal replacement therapy
- preconditioning medication
- Myocardiac infarction within 3 weeks
- active infective endocarditis
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 |
|---|---|---|
| remote ischemic postconditioningRemote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles. | Procedure or surgery | post-ischemic conditioning group |
| valvular surgery with bypassvalvular surgery with bypass | Procedure or surgery | valvular surgery with bypass group |
Primary outcome
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria
Time frame: 5 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 28 Jan 2019.
- Derived from this study: PubMed 30336847Song JW, Lee WK, Lee S, Shim JK, Kim HJ, Kwak YL. Remote ischaemic conditioning for prevention of acute kidney injury after valvular heart surgery: a randomised controlled trial. Br J Anaesth. 2018 Nov;121(5):1034-1040. doi: 10.1016/j.bja.2018.07.035. Epub 2018 Sep 18.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic postconditioning and valvular surgery with bypass in people with Valvular Heart Disease Patients, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 8 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 28 Jan 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720549, which also lists 1 linked publication.
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 28 Jan 2019.