Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

Phase 1

Completed

• Conditions: Cardiac Surgery
• Interventions: Procedure: Remote Ischemic Preconditioning; Other: Control

• Registration Number: NCT00877305
• Lead Sponsor: Patrick Meybohm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2010-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC	Remote Ischemic Preconditioning	Remote Ischemic Preconditioning
CONTROL	Control	Control

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is postoperative neurocognitive dysfunction.	Preoperative, 1 week and 3 months after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany