Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery
NCT ID: NCT00490828
Last Updated: 2008-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2007-06-30
2008-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A
Hydrocortisone
Hydrocortisone
B
Stress doses of hydrocortisone
Hydrocortisone
Hydrocortisone
Interventions
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Hydrocortisone
Hydrocortisone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe liver insufficiency
* Severe renal insufficiency
* Insulin dependent diabetes mellitus
* Steroid therapy
* Psychiatric disease
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Ludwig-Maximilians University, Dept. of Anaesthesiology
Principal Investigators
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Shananz Azad, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology
Locations
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Department of Anesthesiology, University of Munich
Munich, Bavaria, Germany
Countries
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References
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Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
Hauer D, Weis F, Campolongo P, Schopp M, Beiras-Fernandez A, Strewe C, Giehl M, Toth R, Kilger E, Schelling G. Glucocorticoid-endocannabinoid interaction in cardiac surgical patients: relationship to early cognitive dysfunction and late depression. Rev Neurosci. 2012;23(5-6):681-90. doi: 10.1515/revneuro-2012-0058.
Other Identifiers
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149/00
Identifier Type: -
Identifier Source: org_study_id