COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

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. Identifier: NCT00877305
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : January 18, 2012
University of Schleswig-Holstein
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Surgery Procedure: Remote Ischemic Preconditioning Other: Control Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2008
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. The primary outcome measure is postoperative neurocognitive dysfunction. [ Time Frame: Preoperative, 1 week and 3 months after surgery ]

Secondary Outcome Measures :
  1. New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study). [ Time Frame: Within 24-48 hours after surgery ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00877305

Layout table for location information
University Hospital Schleswig-Holstein
Kiel, Germany
Sponsors and Collaborators
Patrick Meybohm
University of Schleswig-Holstein
Layout table for investigator information
Principal Investigator: Patrick Meybohm, MD University of Schleswig-Holstein
Principal Investigator: Berthold Bein, MD University of Schleswig-Holstein
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Patrick Meybohm, PD Dr., University of Schleswig-Holstein Identifier: NCT00877305    
Other Study ID Numbers: A165/08
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Patrick Meybohm, University of Schleswig-Holstein:
Ischemic Preconditioning
Cognitive function