This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Ludwig-Maximilians - University of Munich Identifier:
First received: June 21, 2007
Last updated: September 2, 2008
Last verified: September 2008
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
Other Name: Stress doses of hydrocortisone
Active Comparator: B
Stress doses of hydrocortisone
Drug: 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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00490828

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. Gustav Schelling, Ludwig-Maximilians University, Dept. of Anaesthesiology Identifier: NCT00490828     History of Changes
Other Study ID Numbers: 149/00
Study First Received: June 21, 2007
Last Updated: September 2, 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
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents processed this record on September 21, 2017