Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

NCT ID: NCT00882622

Last Updated: 2012-01-18

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WITHDRAWN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

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation Ventricular Arrythmias Myocardial Injury Cardiac Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RIPC

Group Type ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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.

CONTROL

Group Type SHAM_COMPARATOR

Control/sham procedure

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Control/sham procedure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

Patrick Meybohm

OTHER

Sponsor Role lead

Responsible Party

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Patrick Meybohm

PD Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Hospital

Frankfurt am Main, , Germany

Site Status

University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

Countries

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Germany

Other Identifiers

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A165/08_2

Identifier Type: -

Identifier Source: org_study_id

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