Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

NCT ID: NCT00877305

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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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

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RIPC

Remote Ischemic Preconditioning

Group Type ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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).

CONTROL

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

Patrick Meybohm

OTHER

Sponsor Role lead

Responsible Party

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Patrick Meybohm

PD Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick Meybohm, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Berthold Bein, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

Countries

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Germany

References

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Zitta K, Meybohm P, Bein B, Gruenewald M, Lauer F, Steinfath M, Cremer J, Zacharowski K, Albrecht M. Activities of cardiac tissue matrix metalloproteinases 2 and 9 are reduced by remote ischemic preconditioning in cardiosurgical patients with cardiopulmonary bypass. J Transl Med. 2014 Apr 8;12:94. doi: 10.1186/1479-5876-12-94.

Reference Type DERIVED
PMID: 24712447 (View on PubMed)

Meybohm P, Renner J, Broch O, Caliebe D, Albrecht M, Cremer J, Haake N, Scholz J, Zacharowski K, Bein B. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study. PLoS One. 2013 May 31;8(5):e64743. doi: 10.1371/journal.pone.0064743. Print 2013.

Reference Type DERIVED
PMID: 23741380 (View on PubMed)

Other Identifiers

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A165/08

Identifier Type: -

Identifier Source: org_study_id

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