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Clinical Trials/NCT00877305
NCT00877305CompletedPhase 1

Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

Patrick Meybohm1 site in 1 country180 target enrollmentStarted: October 1, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
The primary outcome measure is postoperative neurocognitive dysfunction.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

The primary outcome measure is postoperative neurocognitive dysfunction.

Time Frame: Preoperative, 1 week and 3 months after surgery

Secondary Outcomes

  • New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study).(Within 24-48 hours after surgery)

Investigators

Sponsor
Patrick Meybohm
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Patrick Meybohm

PD Dr.

University Hospital Schleswig-Holstein

Study Sites (1)

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