Rheumatic Disease of Heart ValveNCT01476969
Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
A study testing Remote ischemic postconditioning in people with Rheumatic Disease of Heart Valve and Ischemic Reperfusion Injury, run by Central South University at 1 site in China.
Trial summary
The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rheumatic Disease of Heart Valve, Ischemic Reperfusion Injury
- What is being tested?
- Remote ischemic postconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Nov 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement
Who cannot join
- infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
- Renal dysfunction
- diabetes
- coronary artery disease
- hypertension
- peripheral vascular disease affecting the lower limb free of arteriovenous fistula
- receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Central South University
Changsha, Hunan, 410008
Luo Wanjun, M.D., 86-731-89753503, luo3478@yahoo.cn
Lv Hongwei, M.D., 86-13467616975, hongweilv@163.com
About this study
The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.
Read the detailed description
Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).
- Being tested
- Remote ischemic postconditioning
- Keywords
- Ischemia reperfusion injury, Cardiopulmonary bypass, Remote Ischemic Postconditioning, Other Functional Disturbances Following Cardiac Surgery
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic postconditioningDevice
Also called Manual Tourniquet YZ-01
the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping.
| Study group | Role | What they receive |
|---|---|---|
| Manual Tourniquet | Experimental | Not described Receives: Device: Remote ischemic postconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Measured: within the first 48h after cardiac surgery
Secondary outcomes (4)
concentration of troponin I (cTnI)
Measured: within 48h after cardiac surgery
Myocardial enzyme
Measured: within 48h after cardiac surgery
Cystatin C
Measured: within 48h after cardiac surgery
High-sensitivity c-reactive protein(HS-CRP)
Measured: within 48h after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Disease of Heart ValveStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Wanjun, Central South University
- Investigators
- Luo Wanjun, M.D., Study director, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476969
- Sponsor's protocol ID
- CentralSouthU
- Status last verified
- Aug 2012
- First submitted
- 16 Nov 2011
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
- ClinicalTrials.gov ID
- NCT01476969
- Acronym / sponsor ID
- CentralSouthU
- Keywords
- Ischemia reperfusion injury, Cardiopulmonary bypass, Remote Ischemic Postconditioning, Other Functional Disturbances Following Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 22 Nov 2011 (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 determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.
Detailed description
Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual Tourniquet | Experimental | Device: Remote ischemic postconditioning |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement
Key exclusion criteria (7 listed)
- infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
- Renal dysfunction
- diabetes
- coronary artery disease
- hypertension
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 postconditioningAlso: Manual Tourniquet YZ-01the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping. | Device | Manual Tourniquet |
Primary outcome
Renal function
Time frame: within the first 48h after cardiac surgery
4 secondary outcomes
concentration of troponin I (cTnI)
Time frame: within 48h after cardiac surgery
Myocardial enzyme
Time frame: within 48h after cardiac surgery
Cystatin C
Time frame: within 48h after cardiac surgery
High-sensitivity c-reactive protein(HS-CRP)
Time frame: within 48h after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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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.
Luo Wanjun, M.D. study director
Central South University
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 in people with Rheumatic Disease of Heart Valve and Ischemic Reperfusion Injury, run by Central South 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Aug 2012. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luo Wanjun, M.D. (86-731-89753503, luo3478@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: within the first 48h after cardiac surgery). 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 14 Aug 2012.