Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury
RIPC
1 other identifier
interventional
160
1 country
1
Brief Summary
The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in patients undergoing cardiac valve replacement surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 9, 2015
June 1, 2015
1.7 years
July 1, 2013
June 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Troponin I change
before induction of anesthesia, postoperative 1, 6, 12, 24, 48, 72 hours
Secondary Outcomes (1)
serum creatinine changes
before induction of anesthesia, postoperative 1, 3, 5 days
Study Arms (2)
delayed remote ischemic preconditioning
EXPERIMENTALapplying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times)
control
PLACEBO COMPARATORAll the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Interventions
In the delayed RIPC group, RIPC is performed 24-48 hr before surgery by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
In the control group, all the procedures were the same with delayed RIPC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Eligibility Criteria
You may qualify if:
- years of adult patient undergoing cardiac valve surgery
You may not qualify if:
- Patient who did not agree to the study
- Emergency operation
- Using inotropics, mechanical assisting device
- Severe liver disease (\>Child class II )
- Severe renal disease (Renal replacement therapy)
- left ventricular ejection fraction \< 30%
- Co-operation of major surgery (Carotid endarterectomy )
- Oral hypoglycemic agent (Sulfonylurea, Glibenclamide)
- peripheral vascular disease affecting upper extremity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Study Officials
- STUDY DIRECTOR
Deok Man Hong, M.D., Ph. D.
Seoul National University Hospital
- STUDY DIRECTOR
Tae Kyong Kim, M.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 19, 2013
Study Start
May 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 9, 2015
Record last verified: 2015-06