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
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery; Systemic Inflammatory Response Syndrome; Health Care Related Quality of Life; Posttraumatic Stress Disorder
Intervention: hydrocortisone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ludwig-Maximilians - University of Munich Official(s) and/or principal investigator(s):
Shananz Azad, M.D., Principal Investigator, Affiliation: Department of Anesthesiology
Overall contact:
Florian C Weis, M.D., Phone: 0049-89-7095-2633, Email: Florian.Weis@med.uni-muenchen.de
Summary
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: Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Florian C Weis, M.D., Phone: 0049-89-7095-2633, Email: Florian.Weis@med.uni-muenchen.de
Department of Anesthesiology, University of Munich, Munich, Bavaria 81377, Germany; Recruiting
gustav Schelling, M.D., Phone: 0049-89-7095-2625, Email: Gustav.Schelling@med.uni-muenchen.de
Florian C Weis, M.D., Principal Investigator
Additional Information
Starting date: June 2007
Ending date: August 2008
Last updated: May 5, 2008
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