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

Phase 4

Completed

• Conditions: Systemic Inflammatory Response Syndrome; Posttraumatic Stress Disorder
• Interventions: Drug: Hydrocortisone

• Registration Number: NCT00490828
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-25
• Primary Completion: 2008-05
• Study Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-02
• Last Update Posted: 2008-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Hydrocortisone	-
B	Hydrocortisone	Stress doses of hydrocortisone

Primary Outcome Measures

Name	Time	Method
immunologic markers, health care related quality of life, PTSD	one and a half year

Secondary Outcome Measures

Name	Time	Method
early clinical outcome parameters (LOS in the ICU)	one year

Trial Locations

Locations (1)

Department of Anesthesiology, University of Munich; 🇩🇪 Munich, Bavaria, Germany