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Remote Ischemic Preconditioning Before Abdominal Surgery

Primary Purpose

Perioperative/Postoperative Complications

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remote Ischemic Pre-conditioning
Control
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perioperative/Postoperative Complications focused on measuring Remote ischemic preconditioning, Abdominal surgery, Perioperative complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic inflammatory disease.
  • Glyburide use before surgery.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Arm remote preconditioning

Control group.

Outcomes

Primary Outcome Measures

Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2011
Last Updated
October 4, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01340742
Brief Title
Remote Ischemic Preconditioning Before Abdominal Surgery
Official Title
Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications
Keywords
Remote ischemic preconditioning, Abdominal surgery, Perioperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Arm remote preconditioning
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Control group.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Pre-conditioning
Intervention Description
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.)
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Cuff placed on arm uninflated for 30 minutes.
Primary Outcome Measure Information:
Title
Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups
Time Frame
One week
Secondary Outcome Measure Information:
Title
Renal function deterioration in the first week after surgery
Description
Baseline Creatinine levels will be compared to the highest creatinine levels noted in the first 7 days of hospitalization
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing abdominal surgery:large bowel, pancreatic and hepatic surgery Exclusion Criteria: Chronic inflammatory disease. Glyburide use before surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronit Lavi, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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Remote Ischemic Preconditioning Before Abdominal Surgery

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