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Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

This study has been completed.
University of Schleswig-Holstein
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein Identifier:
First received: April 6, 2009
Last updated: January 17, 2012
Last verified: January 2012
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Patrick Meybohm, 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 ]

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 ]

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
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00877305

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Patrick Meybohm, PD Dr., University of Schleswig-Holstein Identifier: NCT00877305     History of Changes
Other Study ID Numbers: A165/08
Study First Received: April 6, 2009
Last Updated: January 17, 2012

Keywords provided by Patrick Meybohm, University of Schleswig-Holstein:
Ischemic Preconditioning
Cognitive function processed this record on September 21, 2017