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Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00877305
First Posted: April 7, 2009
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein
  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
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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick Meybohm, PD Dr., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00877305     History of Changes
Other Study ID Numbers: A165/08
First Submitted: April 6, 2009
First Posted: April 7, 2009
Last Update Posted: January 18, 2012
Last Verified: January 2012

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