Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery - Full Text View

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00490828

Purpose

Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.

Condition	Intervention	Phase
Systemic Inflammatory Response Syndrome Posttraumatic Stress Disorder	Drug: Hydrocortisone	Phase IV

MedlinePlus related topics: Heart Surgery Post-Traumatic Stress Disorder

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

immunologic markers, health care related quality of life, PTSD [ Time Frame: one and a half year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

early clinical outcome parameters (LOS in the ICU) [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	June 2007
Study Completion Date:	August 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: Hydrocortisone Hydrocortisone
B: Active Comparator Stress doses of hydrocortisone	Drug: Hydrocortisone Hydrocortisone

Detailed Description:

Methods: Prospective interventional randomized double blind placebo controlled study.

Intervention: Hydrocortisone in stress doses vs. placebo

Patients: 92 high risk patients after cardiac surgery

Measurements: Cytokines, Toll-like receptors, NF kappa B, outcome data, health care related quality of life, PTSD.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min

Exclusion Criteria:

Pregnancy
Severe liver insufficiency
Severe renal insufficiency
Insulin dependent diabetes mellitus
Steroid therapy
Psychiatric disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490828

Locations

Germany, Bavaria
Department of Anesthesiology, University of Munich
Munich, Bavaria, Germany, 81377

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

Principal Investigator:

Shananz Azad, M.D.

Department of Anesthesiology

More Information

Responsible Party:	Ludwig-Maximilians University, Dept. of Anaesthesiology ( Prof. Dr. Gustav Schelling )
Study ID Numbers:	149/00
Study First Received:	June 21, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00490828
Health Authority:	Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:

Cardiac surgery
systemic inflammatory response syndrome
health-related quality of life

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Hydrocortisone
Cortisol succinate
Shock
Anxiety Disorders
Mental Disorders

Quality of Life
Stress Disorders, Post-Traumatic
Stress
Hydrocortisone acetate
Stress Disorders, Traumatic
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Disease

Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009