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

Ludwig Maximilian University of Munich

Status and phase: Completed; Phase 4

Conditions: Posttraumatic Stress Disorder; Systemic Inflammatory Response Syndrome

Treatments: Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00490828

149/00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Hydrocortisone

B

Active Comparator group

Description:

Stress doses of hydrocortisone

Treatment:

Drug: Hydrocortisone