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OpenTrials
Completed

NCT Number: NCT00490828

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

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.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Posttraumatic Stress Disorder Shock Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, University of Munich

Munich, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

Hydrocortisone

Other names: Stress doses of hydrocortisone

Primary outcomes

  1. immunologic markers, health care related quality of life, PTSD

    Time frame: one and a half year

Secondary outcomes

  1. early clinical outcome parameters (LOS in the ICU)

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 25, 2007
Registry last updated
Sep 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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