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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2008

Last Updated Date

January 21, 2010

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00807521 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Steroid-induced Reduction of Surgical Stress Study

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Stenosis
Coronary Artery Bypass Graft Surgery

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
High dose bolus of dexamethasone before surgery

Intervention: Drug: Dexamethasone
Placebo Comparator: 2
Placebo control

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00807521

Other Study ID Numbers ^ICMJE

08/214

Has Data Monitoring Committee

Responsible Party

Prof.dr. S.A. Loer, MD, MSc, VU University Medical Center Amsterdam

Study Sponsor ^ICMJE

VU University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

VU University Medical Center

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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