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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Systemic Inflammatory Response Syndrome Posttraumatic Stress Disorder

Keywords

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Cardiac surgery systemic inflammatory response syndrome health-related quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Hydrocortisone

Intervention Type DRUG

Hydrocortisone

B

Stress doses of hydrocortisone

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type DRUG

Hydrocortisone

Interventions

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Hydrocortisone

Hydrocortisone

Intervention Type DRUG

Other Intervention Names

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Stress doses of hydrocortisone

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

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

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 33045104 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23006898 (View on PubMed)

Other Identifiers

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149/00

Identifier Type: -

Identifier Source: org_study_id