Steroid-induced Reduction of Surgical Stress Study (STRESS)

This study has been withdrawn prior to enrollment.
(Research question was integrated in other study protocol)
Information provided by (Responsible Party):
Christa Boer, VU University Medical Center Identifier:
First received: December 11, 2008
Last updated: December 16, 2014
Last verified: December 2014
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.

Condition Intervention
Coronary Artery Stenosis
Coronary Artery Bypass Graft Surgery
Drug: Dexamethasone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Reduction of the Cardiac Proapoptotic Stress Response by Dexamethasone in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Resource links provided by NLM:

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Expression of p38 in cultured cells and cardiac tissue [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: One week ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2008
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
High dose bolus of dexamethasone before surgery
Drug: Dexamethasone
Single high dose bolus of dexamethasone before surgery
Placebo Comparator: 2
Placebo control
Drug: Placebo
Placebo for dexamethasone


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00807521

VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
Principal Investigator: Jan R. de Jong, MD VU University Medical Center
Study Chair: dr. Christa Boer, PhD VU University Medical Center
Principal Investigator: dr. Everaldo M. Redout, PhD VU University Medical Center
  More Information

Additional Information:
Responsible Party: Christa Boer, Prof.dr. C. Boer, VU University Medical Center Identifier: NCT00807521     History of Changes
Other Study ID Numbers: 08/214 
Study First Received: December 11, 2008
Last Updated: December 16, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Coronary Stenosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses processed this record on May 03, 2016