Effect of treatment with low-dose hydrocortisone on cirrhotic patients presenting with septic shock to the intensive care unit

ISRCTN	ISRCTN99675218
DOI	https://doi.org/10.1186/ISRCTN99675218
Protocol serial number	LG-9-12
Sponsor	King Abdul Aziz City For Science and Technology (Saudi Arabia)
Funder	King Abdul Aziz City for Science and Technology (Saudi Arabia)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Yaseen Arabi
Scientific

P.O. Box 22490
King Fahad National Guard Hospital
ICU 1425
Riyadh
11426
Saudi Arabia

Phone	+966 1 252 0088 Ext 2498
Email	yaseenarabi@yahoo.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The use of hydrocortisone improves the survival of cirrhotics presenting with septic shock.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hydrocortisone
Primary outcome measure(s)	28-all cause mortality
Key secondary outcome measure(s)	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
Completion date	01/04/2006
Reason abandoned (if study stopped)	Objectives no longer viable

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key inclusion criteria	Cirrhotic patients admitted to the Intensive Care Unit with septic shock
Key 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
Date of first enrolment	01/04/2004
Date of final enrolment	01/04/2006

P.O. Box 22490

Riyadh
11426
Saudi Arabia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/12/2010		Yes	No