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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
Information provided by:
Lawson Health Research Institute

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups [ Time Frame: One week ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic inflammatory disease.
  • Glyburide use before surgery.

Information from the National Library of Medicine

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

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
Principal Investigator: Ronit Lavi, MD Lawson Health Research Institute

Responsible Party: Dr. Ronit Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01340742     History of Changes
Other Study ID Numbers: R-10-132
16811 ( Other Identifier: REB )
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by Lawson Health Research Institute:
Remote ischemic preconditioning
Abdominal surgery
Perioperative complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes