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Remote Ischemic Preconditioning Before Abdominal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
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
  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 (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • 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


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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 )
Study First Received: February 14, 2011
Last Updated: June 29, 2011

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 June 26, 2017