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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490828
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : September 3, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Posttraumatic Stress Disorder Drug: Hydrocortisone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery
Study Start Date : June 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Placebo Comparator: A Drug: Hydrocortisone
Other Name: Stress doses of hydrocortisone

Active Comparator: B
Stress doses of hydrocortisone
Drug: Hydrocortisone
Other Name: Stress doses of hydrocortisone

Primary Outcome Measures :
  1. immunologic markers, health care related quality of life, PTSD [ Time Frame: one and a half year ]

Secondary Outcome Measures :
  1. early clinical outcome parameters (LOS in the ICU) [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490828

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Department of Anesthesiology, University of Munich
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Principal Investigator: Shananz Azad, M.D. Department of Anesthesiology

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Gustav Schelling, Ludwig-Maximilians University, Dept. of Anaesthesiology Identifier: NCT00490828     History of Changes
Other Study ID Numbers: 149/00
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: September 2008
Keywords provided by Ludwig-Maximilians - University of Munich:
Cardiac surgery
systemic inflammatory response syndrome
health-related quality of life
Additional relevant MeSH terms:
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Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Systemic Inflammatory Response Syndrome
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anti-Inflammatory Agents