Impact of adrenal gland volume on outcome of septic shock patients

ISRCTN	ISRCTN79359473
DOI	https://doi.org/10.1186/ISRCTN79359473
Secondary identifying numbers	None

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Samir Jaber
Scientific

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

Study design	Single centre observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study objectives	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(s)	Local ethics committee approval
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2007
Completion date	01/05/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Key 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
Key exclusion criteria	1. Chronic steroid consumption 2. Adrenal gland specific pathology prior to admission
Date of first enrolment	01/03/2007
Date of final enrolment	01/05/2010

Service d'Anesthésie-Réanimation B

Montpellier
34295
France

University Teaching Hospital of Montpellier (CHU de Montpellier) (France)
Hospital/treatment centre

191 Avenue du Doyen Gaston Giraud
Montpellier
34295
France

"ROR"	https://ror.org/00mthsf17

Hospital/treatment centre

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No