Contact information
Type
Scientific
Primary contact
Dr Yaseen Arabi
ORCID ID
Contact details
P.O. Box 22490
King Fahad National Guard Hospital
ICU 1425
Riyadh
11426
Saudi Arabia
+966 1 252 0088 Ext 2498
yaseenarabi@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LG-9-12
Study information
Scientific title
Acronym
Study hypothesis
The use of hydrocortisone improves the survival of cirrhotics presenting with septic shock.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Septic shock in cirrhotics
Intervention
This a placebo-controlled double blind randomized controlled trial. The intervention is to give hydrocortisone versus palcebo. Ethic Committee approval date: 26/10/2003.
Intervention type
Drug
Phase
Not Specified
Drug names
Hydrocortisone
Primary outcome measures
28-all cause mortality
Secondary outcome measures
1. Intensive care unit (ICU) mortality
2. Hospital mortality
3. Reversal of shock
4. Vasopressor-free days
5. Mechanical ventilation-free days
6. Renal replacement free days
7. ICU length of stay
8. ICU acquired infection
9. Requirment and duration of vasopressor therapy
Overall trial start date
01/04/2004
Overall trial end date
01/04/2006
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
Cirrhotic patients admitted to the Intensive Care Unit with septic shock
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Pure hypovolemia
2. Hemorrhagic shock
3. Known adrenal insufficiency
4. Prior steroid use
5. Do not resuscitate (DNR) order
6. Patients in terminal condition
7. Contraindication to steroids
8. Refused consent
9. Post-cardiac arrest
10. Patient unexpected to survive 24 hours
Recruitment start date
01/04/2004
Recruitment end date
01/04/2006
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
P.O. Box 22490
Riyadh
11426
Saudi Arabia
Sponsor information
Organisation
King Abdul Aziz City For Science and Technology (Saudi Arabia)
Sponsor details
P.O Box 6086
Riyadh
11442
Saudi Arabia
+966 1 4883444
gdrgp@kacst.edu.sa
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
King Abdul Aziz City for Science and Technology (Saudi Arabia)
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21059778
Publication citations
-
Results
Arabi YM, Aljumah A, Dabbagh O, Tamim HM, Rishu AH, Al-Abdulkareem A, Knawy BA, Hajeer AH, Tamimi W, Cherfan A, Low-dose hydrocortisone in patients with cirrhosis and septic shock: a randomized controlled trial., CMAJ, 2010, 182, 18, 1971-1977, doi: 10.1503/cmaj.090707.