Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

January 17, 2012 updated by: Patrick Meybohm
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany
        • University Hospital Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RIPC
Remote Ischemic Preconditioning
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).
Placebo Comparator: CONTROL
Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is postoperative neurocognitive dysfunction.
Time Frame: Preoperative, 1 week and 3 months after surgery
Preoperative, 1 week and 3 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patrick Meybohm

Collaborators

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Patrick Meybohm, MD, University Hospital Schleswig-Holstein
  • Principal Investigator: Berthold Bein, MD, University Hospital Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A165/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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