Text Size

Remote Ischemic Preconditioning Before Abdominal Surgery

This study is currently recruiting participants.
Verified June 2011 by Lawson Health Research Institute
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01340742
First received: February 14, 2011
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  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, 2013