Remote Ischemic Preconditioning Before Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT01340742|
Recruitment Status : Unknown
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was: Recruiting
First Posted : April 25, 2011
Last Update Posted : July 1, 2011
Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.
Ischemic preconditioning may have a protective effect. The purpose of this study is to find out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a protective effect.
|Condition or disease||Intervention/treatment||Phase|
|Perioperative/Postoperative Complications||Procedure: Remote Ischemic Pre-conditioning Procedure: Control||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
Active Comparator: 1
Arm remote preconditioning
Procedure: Remote Ischemic Pre-conditioning
Cuff placed on arm. Three 5- minute cycles of blood pressure cuff inflation: cuff is inflated to 200 mm Hg for 5 minutes followed by a 5-minute deflation (reperfusion.)
Placebo Comparator: 2
Cuff placed on arm uninflated for 30 minutes.
- Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups [ Time Frame: One week ]
- Renal function deterioration in the first week after surgery [ Time Frame: One week ]Baseline Creatinine levels will be compared to the highest creatinine levels noted in the first 7 days of hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340742
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Ronit Lavi, MD 519-685-8500 ext 33384 firstname.lastname@example.org|
|Principal Investigator: Ronit Lavi, MD|
|Principal Investigator:||Ronit Lavi, MD||Lawson Health Research Institute|