Steroid-induced Reduction of Surgical Stress Study (STRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807521
Recruitment Status : Withdrawn (Research question was integrated in other study protocol)
First Posted : December 12, 2008
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):
Christa Boer, VU University Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenosis Coronary Artery Bypass Graft Surgery Drug: Dexamethasone Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Reduction of the Cardiac Proapoptotic Stress Response by Dexamethasone in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study Start Date : December 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Expression of p38 in cultured cells and cardiac tissue [ Time Frame: One week ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action