Remote Ischemic Preconditioning Before Abdominal Surgery

This study is currently recruiting participants.

Verified June 2011 by Lawson Health Research Institute

First Received on February 14, 2011. Last Updated on June 29, 2011 History of Changes

Sponsor:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01340742

Purpose

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	Intervention	Phase
Perioperative/Postoperative Complications	Procedure: Remote Ischemic Pre-conditioning Procedure: Control	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Renal function deterioration in the first week after surgery [ Time Frame: One week ] [ Designated as safety issue: No ]
Baseline Creatinine levels will be compared to the highest creatinine levels noted in the first 7 days of hospitalization

Estimated Enrollment:	440
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Control group.	Procedure: Control Cuff placed on arm uninflated for 30 minutes.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing abdominal surgery:large bowel, pancreatic and hepatic surgery

Exclusion Criteria:

Chronic inflammatory disease.
Glyburide use before surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340742

Locations

Canada, Ontario
London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Ronit Lavi, MD 519-685-8500 ext 33384 ronit.lavi@lhsc.on.ca
Principal Investigator: Ronit Lavi, MD

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:

Ronit Lavi, MD

Lawson Health Research Institute

More Information

No publications provided

Responsible Party:	Dr. Ronit Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01340742 History of Changes
Other Study ID Numbers:	R-10-132, 16811
Study First Received:	February 14, 2011
Last Updated:	June 29, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

Remote ischemic preconditioning
Abdominal surgery
Perioperative complications

Additional relevant MeSH terms:

Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012