Steroid-induced Reduction of Surgical Stress Study (STRESS)
Primary Purpose
Coronary Artery Stenosis, Coronary Artery Bypass Graft Surgery
Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Stenosis
Eligibility 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
Sites / Locations
- VU University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
High dose bolus of dexamethasone before surgery
Placebo control
Outcomes
Primary Outcome Measures
Expression of p38 in cultured cells and cardiac tissue
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
Full Information
NCT ID
NCT00807521
First Posted
December 11, 2008
Last Updated
December 16, 2014
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT00807521
Brief Title
Steroid-induced Reduction of Surgical Stress Study
Acronym
STRESS
Official Title
Reduction of the Cardiac Proapoptotic Stress Response by Dexamethasone in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Research question was integrated in other study protocol
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis, Coronary Artery Bypass Graft Surgery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
High dose bolus of dexamethasone before surgery
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo control
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Single high dose bolus of dexamethasone before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for dexamethasone
Primary Outcome Measure Information:
Title
Expression of p38 in cultured cells and cardiac tissue
Time Frame
One week
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan R. de Jong, MD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
dr. Christa Boer, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
dr. Everaldo M. Redout, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://www.vumc.nl
Description
General website of site
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Steroid-induced Reduction of Surgical Stress Study
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