NCT00862381

Brief Summary

the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

Enrollment Period

1.7 years

First QC Date

March 13, 2009

Last Update Submit

July 23, 2010

Conditions

Patient Admitted in Reanimation

Keywords

shockTracheal Intubationreanimationsuprarenal insufficiencyEtomidateAdrenocorticotropic Hormonehydrocortisone

Outcome Measures

Primary Outcomes (3)

  • diminution of 50% of the proportion of patients with a score SOFA of 3 or 4

    12h, 24h and 48h after the injection of hydrocortisone

  • mean arterial blood pressure

    during the hospitalisation

  • plasmatic cortisol and substance S before and after ACTH stimulation

    h-4; h6; h12 and h24

Secondary Outcomes (7)

  • clinical state

    12h and 24h

  • hospitalisation duration in reanimation

    until day28

  • duration of mechanical ventilation

    until day28

  • duration and posology of adrenaline and noradrenaline

    h0, h4, h6, h12, h24 and h48

  • complications during hospitalization in reanimation potentially due to HSHC

    until day28

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Hydrocortisone

Drug: Hydrocortisone

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

HydrocortisoneDRUG

hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment

1
PlaceboDRUG

NaCl 0.9%

2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received an unique injection of etomidate in pre-hospital situation or at "déchocage" in the previous 6 hours.
  • informed consent signed by the patient or the reliable person
  • affiliation to a regime of social security

You may not qualify if:

  • persons aimed at the articles L. 1121-5 à L. 1121-8 of the french code of public health
  • toxic shock requiring a treatment by HSHC inn accordance with the criteria of Annane et Al. \[13\]
  • purpura fulminans
  • chronicle suprarenal insufficiency
  • patients likely to present an acute suprarenal insufficiency : current treatment with antifungal : ketoconazole or fluconazole, known HIV infection, Sheehan syndrome
  • corticotherapy in the 6 last months
  • initiation of hydrocortisone therapy out of the study
  • survival estimated at less than 48 hours
  • no benefits of social security
  • refusal to participate by patient or reliable person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne

Annecy, France

Location

Pôle d'anesthésie - réanimation, University Hospital of Grenoble

Grenoble, France

Location

Related Publications (1)

  • Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial. Crit Care Med. 2012 Jan;40(1):29-35. doi: 10.1097/CCM.0b013e31822d7938.

    PMID: 21926601DERIVED

MeSH Terms

Conditions

Shock

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Christophe PH, BROUX

    University Hospital of Grenoble, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations

FR(2)