Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Sponsor

Patrick Meybohm (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00882622

Collaborator

University Hospital Frankfurt (Other)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Ventricular Arrythmias Myocardial Injury Cardiac Function	Procedure: Remote Ischemic Preconditioning Procedure: Control/sham procedure	Phase 1

Detailed Description

In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RIPC	Procedure: Remote Ischemic Preconditioning RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.
Sham Comparator: CONTROL	Procedure: Control/sham procedure Sham placement of the blood pressure cuff around the upper limb without inflation.

Arm

Intervention/Treatment

Active Comparator: RIPC

Procedure: Remote Ischemic Preconditioning

RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.

Sham Comparator: CONTROL

Procedure: Control/sham procedure

Sham placement of the blood pressure cuff around the upper limb without inflation.

Outcome Measures

Primary Outcome Measures

New onset of atrial fibrillation [Within 30 days after surgery]

Secondary Outcome Measures

Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response. [Within 24 hours after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

Emergency cases
Myocardial infarction up to 7 days prior to enrollment
Ejection fraction less than 30%
Inability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Frankfurt am Main		Germany
2	University Hospital Schleswig-Holstein	Kiel		Germany	24105

Sponsors and Collaborators

Patrick Meybohm
University Hospital Frankfurt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patrick Meybohm, PD Dr., University Hospital Schleswig-Holstein

ClinicalTrials.gov Identifier:

NCT00882622

Other Study ID Numbers:

A165/08_2

First Posted:

Apr 16, 2009

Last Update Posted:

Jan 18, 2012

Last Verified:

Jan 1, 2012

Keywords provided by Patrick Meybohm, PD Dr., University Hospital Schleswig-Holstein

Ischemic Preconditioning

Cardiac Surgery

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Jan 18, 2012