Low-dose Hydrocortisone in Acutely Burned Patients

NCT ID: NCT00149123

Last Updated: 2015-02-12

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-10-31

Brief Summary

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Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.

Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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hydrocortisone 200 mg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* males and females,
* between 18 and 75 year old
* who present a burned surface more than 30% of the body surface
* who need catecholamine infusion
* between J0 and J3 after the injury.

Exclusion Criteria

* pregnancy,
* trauma,
* sepsis,
* cardiac insufficiency,
* AIDS,
* etomidate administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Principal Investigators

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Sylvie TISSOT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Sylvie TISSOT

Lyon, , France

Site Status

Countries

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France

References

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Plassais J, Venet F, Cazalis MA, Le Quang D, Pachot A, Monneret G, Tissot S, Textoris J. Transcriptome modulation by hydrocortisone in severe burn shock: ancillary analysis of a prospective randomized trial. Crit Care. 2017 Jun 16;21(1):158. doi: 10.1186/s13054-017-1743-9.

Reference Type DERIVED
PMID: 28623938 (View on PubMed)

Venet F, Plassais J, Textoris J, Cazalis MA, Pachot A, Bertin-Maghit M, Magnin C, Rimmele T, Monneret G, Tissot S. Low-dose hydrocortisone reduces norepinephrine duration in severe burn patients: a randomized clinical trial. Crit Care. 2015 Jan 26;19(1):21. doi: 10.1186/s13054-015-0740-0.

Reference Type DERIVED
PMID: 25619170 (View on PubMed)

Other Identifiers

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2004.354

Identifier Type: -

Identifier Source: org_study_id

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