Remote Ischemic Preconditioning Before Abdominal Surgery

Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications

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.

Study Overview

• Status: Withdrawn
• Conditions: Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: Remote Ischemic Pre-conditioning; Procedure: Control

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Chronic inflammatory disease.
• Glyburide use before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function deterioration in the first week after surgery	Baseline Creatinine levels will be compared to the highest creatinine levels noted in the first 7 days of hospitalization	One week

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Ronit Lavi, MD, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Estimated): June 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimated): April 25, 2011

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Remote ischemic preconditioning; Abdominal surgery; Perioperative complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: R-10-132; 16811 (REB)