NCT01340742

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

February 14, 2011

Last Update Submit

October 4, 2023

Conditions

Perioperative/Postoperative Complications

Keywords

Remote ischemic preconditioningAbdominal surgeryPerioperative complications

Outcome Measures

Primary Outcomes (1)

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

    One week

Secondary Outcomes (1)

  • Renal function deterioration in the first week after surgery

    One week

Study Arms (2)

1

ACTIVE COMPARATOR

Arm remote preconditioning

Procedure: Remote Ischemic Pre-conditioning

2

PLACEBO COMPARATOR

Control group.

Procedure: Control

Interventions

Remote Ischemic Pre-conditioningPROCEDURE

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.)

1
ControlPROCEDURE

Cuff placed on arm uninflated for 30 minutes.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chronic inflammatory disease.
  • Glyburide use before surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ronit Lavi, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

April 25, 2011

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

CA(1)