Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

This study has been withdrawn prior to enrollment.
(Endpoints were investigated in parallel in NCT00877305)
Sponsor:
Collaborator:
University Hospital, Frankfurt
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00882622
First received: April 14, 2009
Last updated: January 17, 2012
Last verified: January 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
University Hospital
Frankfurt am Main, Germany
University Hospital Schleswig-Holstein
Kiel, Germany, 24105
Sponsors and Collaborators
Patrick Meybohm
University Hospital, Frankfurt
  More Information

No publications provided

Responsible Party: Patrick Meybohm, PD Dr., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00882622     History of Changes
Other Study ID Numbers: A165/08_2
Study First Received: April 14, 2009
Last Updated: January 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
Ischemic Preconditioning
Cardiac Surgery

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014