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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Official Title:	Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Post-Traumatic Stress Disorder

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

U.S. FDA Resources

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
Placebo Comparator: A	Drug: Hydrocortisone Hydrocortisone Other Name: Stress doses of hydrocortisone
Active Comparator: B Stress doses of hydrocortisone	Drug: Hydrocortisone Hydrocortisone Other Name: Stress doses of 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
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

No publications provided

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

Keywords provided by Ludwig-Maximilians - University of Munich:

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

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Systemic Inflammatory Response Syndrome
Anxiety Disorders
Mental Disorders
Inflammation
Pathologic Processes

Shock
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012