Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

Patrick Meybohm

Status and phase: Completed; Phase 1

Conditions: Cardiac Surgery

Treatments: Procedure: Remote Ischemic Preconditioning; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT00877305

A165/08

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups, including a placebo group

RIPC

Active Comparator group

Description:

Remote Ischemic Preconditioning

Treatment:

Procedure: Remote Ischemic Preconditioning

CONTROL

Placebo Comparator group

Description:

Control

Treatment:

Other: Control