Steroid-induced Reduction of Surgical Stress Study

Coronary Artery Stenosis Clinical Trial

— STRESS  

Official title:

Reduction of the Cardiac Proapoptotic Stress Response by Dexamethasone in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00807521
• Other study ID #: 08/214
• Status: Withdrawn
• Phase: N/A
• First received: December 11, 2008
• Last updated: December 16, 2014
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2014
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Drug:
• Dexamethasone
Single high dose bolus of dexamethasone before surgery
• Placebo
Placebo for dexamethasone

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of p38 in cultured cells and cardiac tissue		One week	No
Secondary	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	No

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