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Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00877305
First received: April 6, 2009
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cardiac Surgery
 Procedure: Remote Ischemic Preconditioning
Other: Control
 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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

Primary Outcome Measures:
  • The primary outcome measure is postoperative neurocognitive dysfunction. [ Time Frame: Preoperative, 1 week and 3 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study). [ Time Frame: Within 24-48 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: October 2008
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RIPC
Remote Ischemic Preconditioning
 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 200 mmHg (at least a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line).
Placebo Comparator: CONTROL
Control
 Other: Control
Sham intervention with four 5-min cycles of inflation of the blood pressure cuff at 20 mmHg and 5 min deflation without any upper leg ischaemia.

  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
  • Stroke up to 2 months prior to enrollment
  • Ejection fraction less than 30%
  • Previous psychiatric and neurological illness
  • Inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877305

Locations
Germany
University Hospital Schleswig-Holstein
Kiel, Germany
Sponsors and Collaborators
Patrick Meybohm
University of Schleswig-Holstein
Investigators
Principal Investigator: Patrick Meybohm, MD University of Schleswig-Holstein
Principal Investigator: Berthold Bein, MD University of Schleswig-Holstein
  More Information

No publications provided

Responsible Party: Patrick Meybohm, PD Dr., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00877305     History of Changes
Other Study ID Numbers: A165/08
Study First Received: April 6, 2009
Last Updated: January 17, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Ischemic Preconditioning
Cognitive function

ClinicalTrials.gov processed this record on May 19, 2013