Steroid-induced Reduction of Surgical Stress Study (STRESS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by VU University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00807521
First received: December 11, 2008
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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 ]

Estimated Enrollment: 96
Study Start Date: December 2008
Estimated Study Completion Date: June 2011
Estimated 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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807521

Contacts
Contact: Dr. Christa Boer, PhD +31204443830 c.boer@vumc.nl
Contact: Jan R. de Jong, MD +31204444386 jr.dejong@vumc.nl

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

Additional Information:
No publications provided

Responsible Party: Prof.dr. S.A. Loer, MD, MSc, VU University Medical Center Amsterdam
ClinicalTrials.gov Identifier: NCT00807521     History of Changes
Other Study ID Numbers: 08/214
Study First Received: December 11, 2008
Last Updated: January 21, 2010
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
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
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

ClinicalTrials.gov processed this record on October 23, 2014