Remote Ischemic Preconditioning Before Abdominal Surgery

NCT ID: NCT01340742

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Perioperative/Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Arm remote preconditioning

Group Type ACTIVE_COMPARATOR

Remote Ischemic Pre-conditioning

Intervention Type PROCEDURE

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.)

2

Control group.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

Cuff placed on arm uninflated for 30 minutes.

Interventions

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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.)

Intervention Type PROCEDURE

Control

Cuff placed on arm uninflated for 30 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Chronic inflammatory disease.
* Glyburide use before surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronit Lavi, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16811

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-132

Identifier Type: -

Identifier Source: org_study_id

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