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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490828
• Other study ID #: 149/00
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2007
• Last updated: September 2, 2008
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Systemic Inflammatory Response Syndrome

Intervention

Drug:
• Hydrocortisone
Hydrocortisone

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University of Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunologic markers, health care related quality of life, PTSD		one and a half year	No
Secondary	early clinical outcome parameters (LOS in the ICU)		one year	No