Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877305
• Other study ID #: A165/08
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2009
• Last updated: January 17, 2012
• Start date: October 2008

Study information

• Verified date: January 2012
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Patrick Meybohm	University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is postoperative neurocognitive dysfunction.		Preoperative, 1 week and 3 months after surgery	No
Secondary	New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study).		Within 24-48 hours after surgery	No