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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490828
First Posted: June 25, 2007
Last Update Posted: September 3, 2008
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.
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose
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 Intervention Phase
Systemic Inflammatory Response Syndrome Posttraumatic Stress Disorder Drug: Hydrocortisone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

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

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

Enrollment: 120
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Hydrocortisone
Hydrocortisone
Other Name: Stress doses of hydrocortisone
Active Comparator: B
Stress doses of hydrocortisone
Drug: Hydrocortisone
Hydrocortisone
Other Name: Stress doses of hydrocortisone

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00490828


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Gustav Schelling, Ludwig-Maximilians University, Dept. of Anaesthesiology
ClinicalTrials.gov Identifier: NCT00490828     History of Changes
Other Study ID Numbers: 149/00
First Submitted: June 21, 2007
First Posted: June 25, 2007
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:
Stress Disorders, Post-Traumatic
Systemic Inflammatory Response Syndrome
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Inflammation
Pathologic Processes
Shock
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents