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

April 6, 2009
January 17, 2012
October 2008
November 2010   (final data collection date for primary outcome measure)
The primary outcome measure is postoperative neurocognitive dysfunction. [ Time Frame: Preoperative, 1 week and 3 months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00877305 on ClinicalTrials.gov Archive Site
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 ]
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Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery
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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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiac Surgery
  • 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).
  • 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.
  • Active Comparator: RIPC
    Remote Ischemic Preconditioning
    Intervention: Procedure: Remote Ischemic Preconditioning
  • Placebo Comparator: CONTROL
    Control
    Intervention: Other: Control
Meybohm P, Renner J, Broch O, Caliebe D, Albrecht M, Cremer J, Haake N, Scholz J, Zacharowski K, Bein B. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study. PLoS One. 2013 May 31;8(5):e64743. doi: 10.1371/journal.pone.0064743. Print 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
Not Provided
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00877305
A165/08
No
Patrick Meybohm, University of Schleswig-Holstein
Patrick Meybohm
University of Schleswig-Holstein
Principal Investigator: Patrick Meybohm, MD University of Schleswig-Holstein
Principal Investigator: Berthold Bein, MD University of Schleswig-Holstein
University of Schleswig-Holstein
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP