Posttraumatic Stress Disorder, Systemic Inflammatory Response Syndrome
Conditions
Keywords
Cardiac surgery, systemic inflammatory response syndrome, health-related quality of life
Brief 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.
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.
Interventions
DRUGHydrocortisone
Hydrocortisone
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immunologic markers, health care related quality of life, PTSD | one and a half year |
Secondary
| Measure | Time frame |
|---|---|
| early clinical outcome parameters (LOS in the ICU) | one year |
Countries
Germany
Outcome results
None listed