Effect of treatment with low-dose hydrocortisone on cirrhotic patients presenting with septic shock to the intensive care unit
ISRCTN | ISRCTN99675218 |
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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
Scientific
P.O. Box 22490
King Fahad National Guard Hospital
ICU 1425
Riyadh
11426
Saudi Arabia
Phone | +966 1 252 0088 Ext 2498 |
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yaseenarabi@yahoo.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Hydrocortisone |
Primary outcome measure | 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 study start date | 01/04/2004 |
Completion date | 01/04/2006 |
Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
P.O. Box 22490
Riyadh
11426
Saudi Arabia
11426
Saudi Arabia
Sponsor information
King Abdul Aziz City For Science and Technology (Saudi Arabia)
Research organisation
Research organisation
P.O Box 6086
Riyadh
11442
Saudi Arabia
Phone | +966 1 4883444 |
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gdrgp@kacst.edu.sa | |
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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 14/12/2010 | Yes | No |