Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/03/2010
Date assigned
27/04/2010
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Samir Jaber

ORCID ID

Contact details

Service d'Anesthésie-Réanimation B
Unité de Réanimation et Transplantation
Hôpital Saint Eloi
80 Avenue Augustin Fliche
Montpellier
34295
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

None

Study information

Scientific title

Impact of adrenal gland volume measured non invasively with a CT scan on outcome of septic shock patients admitted in the Intensive Care Unit: A single centre, observational trial

Acronym

Study hypothesis

1. To assess the impact of adrenal gland volume measured non invasively with a CT scan on outcome of septic shock patients admitted in the Intensive Care Unit.
2. To compare adrenal gland volume between septic and non septic patients.
3. To examine the relationship between adrenal gland volume and adrenal gland function assessed by hormonal tests.

Ethics approval

Local ethics committee approval

Study design

Single centre observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Septic Shock; Adrenal gland; Critical Illness related Corticoid Insuffisency

Intervention

Observational trial of patients receiving routine care with an abdominal CT scan

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mortality at day 28

Secondary outcome measures

1. ICU length of mechanical ventilation
2. ICU length of stay
3. Adrenal function in univariate and multivariate analysis
4. Adrenal gland volume comparison between septic and non septic patients

Overall trial start date

01/03/2007

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Septic shock patients: septic shock defined using the Bone guidelines (Bone et al, Chest 1992;101(6):1644-55) admitted in the ICU and explored both with a short cosyntropin test and an abdominal CT scan
2. Non septic patients admitted to Intensive Care Unit with explored abdominal CT scan
3. Outpatients clinic patients explored for abdominal pain with a normal CT scan
4. Male and female, age ≥ 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Chronic steroid consumption
2. Adrenal gland specific pathology prior to admission

Recruitment start date

01/03/2007

Recruitment end date

01/05/2010

Locations

Countries of recruitment

France

Trial participating centre

Service d'Anesthésie-Réanimation B
Montpellier
34295
France

Sponsor information

Organisation

University Teaching Hospital of Montpellier (CHU de Montpellier) (France)

Sponsor details

191 Avenue du Doyen Gaston Giraud
Montpellier
34295
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Saint Eloi Hospital (France) - Intensive Care and Transplantation Unit (Unité de Réanimation et Transplantation)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21720239

Publication citations

  1. Results

    Jung B, Nougaret S, Chanques G, Mercier G, Cisse M, Aufort S, Gallix B, Annane D, Jaber S, The absence of adrenal gland enlargement during septic shock predicts mortality: a computed tomography study of 239 patients., Anesthesiology, 2011, 115, 2, 334-343, doi: 10.1097/ALN.0b013e318225cfd7.

Additional files

Editorial Notes