Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery - Full Text View

Sponsors and Collaborators:	University of Schleswig-Holstein University Hospital, Frankfurt
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00882622

Purpose

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	Intervention	Phase
Atrial Fibrillation Ventricular Arrythmias Myocardial Injury Cardiac Function	Procedure: Remote Ischemic Preconditioning Procedure: Control/sham procedure	Phase I

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:

New onset of atrial fibrillation [ Time Frame: Within 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response. [ Time Frame: Within 24 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RIPC: Active Comparator	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.
CONTROL: Sham Comparator	Procedure: Control/sham procedure Sham placement of the blood pressure cuff around the upper limb without inflation.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882622

Contacts

Contact: Patrick Meybohm, MD

+494315972965

meybohm@anaesthesie.uni-kiel.de

Locations

Germany
University Hospital Schleswig-Holstein	Recruiting
Kiel, Germany, 24105
Contact: Patrick Meybohm, MD meybohm@anaesthesie.uni-kiel.de
Principal Investigator: Patrick Meybohm, MD
Principal Investigator: Berthold Bein, MD, DEEA
Principal Investigator: Martin Albrecht, PhD
Principal Investigator: Jochen Cremer, MD
University Hospital	Not yet recruiting
Frankfurt am Main, Germany
Contact: Kai Zacharowski, PhD
Principal Investigator: Kai Zacharowski, PhD

Sponsors and Collaborators

University of Schleswig-Holstein

University Hospital, Frankfurt

More Information

No publications provided

Responsible Party:	Department of Anaesthesiology and Intensive Care Medicine ( University Hospital Schleswig-Holstein )
Study ID Numbers:	A165/08_2
Study First Received:	April 14, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00882622 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:

Ischemic Preconditioning
Cardiac Surgery

Study placed in the following topic categories:

Heart Diseases
Anesthetics
Ischemia
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009