Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedSeptember 3, 2008
September 1, 2008
11 months
June 21, 2007
September 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
immunologic markers, health care related quality of life, PTSD
one and a half year
Secondary Outcomes (1)
early clinical outcome parameters (LOS in the ICU)
one year
Study Arms (2)
A
PLACEBO COMPARATORB
ACTIVE COMPARATORStress doses of hydrocortisone
Interventions
Eligibility Criteria
You may qualify if:
- Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min
You may not qualify if:
- Pregnancy
- Severe liver insufficiency
- Severe renal insufficiency
- Insulin dependent diabetes mellitus
- Steroid therapy
- Psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, University of Munich
Munich, Bavaria, 81377, Germany
Related Publications (2)
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.
PMID: 33045104DERIVEDHauer 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.
PMID: 23006898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shananz Azad, M.D.
Department of Anesthesiology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 25, 2007
Study Start
June 1, 2007
Primary Completion
May 1, 2008
Study Completion
August 1, 2008
Last Updated
September 3, 2008
Record last verified: 2008-09