NCT00490828

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Inflammatory Response Syndrome
• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Hydrocortisone	Hydrocortisone

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-05-01
• Completion: 2008-08-01
• First posted: 2007-06-25
• Last updated: 2008-09-03

Locations

1 site across 1 country: Germany