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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21720239
Publication citations
-
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.