Steroid-induced Reduction of Surgical Stress Study

Not Applicable

Withdrawn

• Conditions: Coronary Artery Bypass Graft Surgery; Coronary Artery Stenosis
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT00807521
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo control
1	Dexamethasone	High dose bolus of dexamethasone before surgery

Primary Outcome Measures

Name	Time	Method
Expression of p38 in cultured cells and cardiac tissue	One week

Secondary Outcome Measures

Name	Time	Method
Pro-apoptotic signaling, precursor peptides of ANP (proANP), vasopressin (Copeptin), proET-1 and Adrenomedullin (proADM). Age, gender, length, body weight, hematocrit, Hb, leukocytes, surgery time, clamp time, CPB time	One week

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands