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

Ludwig-Maximilians - University of Munich120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

120

Conditions

Systemic Inflammatory Response Syndrome Posttraumatic Stress Disorder

Interventions

HydrocortisoneDRUG

Hydrocortisone

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology, University of Munich

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

immunologic markers, health care related quality of life, PTSD

Time frame: one and a half year

Secondary Outcomes

early clinical outcome parameters (LOS in the ICU)

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.