DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Inflammatory Response Syndrome; Posttraumatic Stress Disorder

Intervention: Hydrocortisone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ludwig-Maximilians - University of Munich

Official(s) and/or principal investigator(s):
Shananz Azad, M.D., Principal Investigator, Affiliation: Department of Anesthesiology


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.

Clinical Details

Official title: Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Primary outcome: immunologic markers, health care related quality of life, PTSD

Secondary outcome: early clinical outcome parameters (LOS in the ICU)

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

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

Starting date: June 2007
Last updated: September 2, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017