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Steroid-induced Reduction of Surgical Stress Study

NCT ID: NCT00807521

Last Updated: 2014-12-17

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-06-30

Brief Summary

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The stress response as induced by myocardial cellular damage during cardiac surgery may lead to myocardial stunning and apoptosis, and could therefore impair postoperative patient recovery. Surgical trauma typically induces the liberation of cytokines. Some of these cytokines are strongly associated with the initiation of intracellular proapoptotic pathways through activation of tyrosine kinases and integrins. The latter are known for their deteriorating effects on cardiac function and are strongly involved in cardiac remodeling. Dexamethasone is typically administered prior to cardiac surgery in order to especially reduce the release of proinflammatory cytokines. It has however never been investigated whether this additionally reduces proapoptotic signaling in the human heart, thereby eliminating risk factors for the induction of cardiac dysfunction. In the present study, the investigators therefore aim to investigate whether dexamethasone inhibits proapoptotic pathways in patients undergoing cardiac surgery. Furthermore, the investigators would like to elucidate whether this proposed effect of dexamethasone is related to the reduction of the stress response in the heart or indirectly by suppression of cytokine release. For this purpose the investigators will obtain cardiac biopsies and plasma from patients, who are randomly assigned to placebo or dexamethasone treatment and undergo on and off-pump coronary artery bypass grafting (CABG) surgery.

Detailed Description

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Conditions

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Coronary Artery Stenosis Coronary Artery Bypass Graft Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

High dose bolus of dexamethasone before surgery

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Single high dose bolus of dexamethasone before surgery

2

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for dexamethasone

Interventions

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Dexamethasone

Single high dose bolus of dexamethasone before surgery

Intervention Type DRUG

Placebo

Placebo for dexamethasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing coronary artery bypass surgery (CABG)
* Age 18-75 years
* Informed consent

Exclusion Criteria

* Re-operations and emergency operations
* Patient with anemia (Hb \< 5.0)
* Emergency operation
* Patients receiving blood transfusions \< 3 months before operation
* Insulin depended diabetes mellitus
* Hepatic or renal failure
* Pregnancy
* Use of steroids
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Christa Boer

Prof.dr. C. Boer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan R. de Jong, MD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

dr. Christa Boer, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

dr. Everaldo M. Redout, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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http://www.vumc.nl

General website of site

Other Identifiers

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08/214

Identifier Type: -

Identifier Source: org_study_id