Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 6, 2009
CompletedFirst Posted
Study publicly available on registry
April 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedJanuary 18, 2012
January 1, 2012
2.1 years
April 6, 2009
January 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is postoperative neurocognitive dysfunction.
Preoperative, 1 week and 3 months after surgery
Secondary Outcomes (1)
New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study).
Within 24-48 hours after surgery
Study Arms (2)
RIPC
ACTIVE COMPARATORRemote Ischemic Preconditioning
CONTROL
PLACEBO COMPARATORControl
Interventions
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).
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 Criteria
You may qualify if:
- Patient undergoing heart surgery on cardiopulmonary bypass
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Patrick Meybohmlead
- University Hospital Schleswig-Holsteincollaborator
Study Sites (1)
University Hospital Schleswig-Holstein
Kiel, Germany
Related Publications (2)
Zitta K, Meybohm P, Bein B, Gruenewald M, Lauer F, Steinfath M, Cremer J, Zacharowski K, Albrecht M. Activities of cardiac tissue matrix metalloproteinases 2 and 9 are reduced by remote ischemic preconditioning in cardiosurgical patients with cardiopulmonary bypass. J Transl Med. 2014 Apr 8;12:94. doi: 10.1186/1479-5876-12-94.
PMID: 24712447DERIVEDMeybohm 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.
PMID: 23741380DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Meybohm, MD
University Hospital Schleswig-Holstein
- PRINCIPAL INVESTIGATOR
Berthold Bein, MD
University Hospital Schleswig-Holstein
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PD Dr.
Study Record Dates
First Submitted
April 6, 2009
First Posted
April 7, 2009
Study Start
October 1, 2008
Primary Completion
November 1, 2010
Last Updated
January 18, 2012
Record last verified: 2012-01