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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:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00490828
First received: June 21, 2007
Last updated: September 2, 2008
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • early clinical outcome parameters (LOS in the ICU) [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Ludwig-Maximilians - University of Munich

Additional 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
Study First Received: June 21, 2007
Last Updated: September 2, 2008
Health Authority: Germany: Ethics Commission

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
Stress Disorders, Traumatic
Systemic Inflammatory Response Syndrome
Anxiety Disorders
Mental Disorders
Inflammation
Pathologic Processes
Shock
Cortisol succinate
 Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013