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
Secondary identifying numbers LG-9-12
Submission date
18/07/2005
Registration date
08/09/2005
Last edited
25/01/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Infections and Infestations
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

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedSeptic shock in cirrhotics
InterventionThis a placebo-controlled double blind randomized controlled trial. The intervention is to give hydrocortisone versus palcebo. Ethic Committee approval date: 26/10/2003.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hydrocortisone
Primary outcome measure28-all cause mortality
Secondary outcome measures1. 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 study start date01/04/2004
Completion date01/04/2006
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteriaCirrhotic patients admitted to the Intensive Care Unit with septic shock
Key exclusion criteria1. 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 enrolment01/04/2004
Date of final enrolment01/04/2006

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

P.O. Box 22490
Riyadh
11426
Saudi Arabia

Sponsor information

King Abdul Aziz City For Science and Technology (Saudi Arabia)
Research organisation

P.O Box 6086
Riyadh
11442
Saudi Arabia

Phone +966 1 4883444
Email gdrgp@kacst.edu.sa
ROR logo "ROR" https://ror.org/05tdz6m39

Funders

Funder type

Research organisation

King Abdul Aziz City for Science and Technology (Saudi Arabia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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