Clinical Value of Remote Ischemic Preconditioning
Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?|
- Postoperative atrial fibrillation [ Time Frame: Up to 10 days after surgery ] [ Designated as safety issue: No ]A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.
- Length of hospital stay [ Time Frame: Maximum 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.
The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.
No Intervention: No RIPC
Patients in the control group will not receive remote ischemic preconditioning before the surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740102
|St Olavs Hospital Trondheim University Hospital|
|Study Director:||Alexander Wahba, MD prof||Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.|
|Principal Investigator:||Lars Erik B Krogstad||Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.|