Condition category
Infections and Infestations
Date applied
18/07/2005
Date assigned
08/09/2005
Last edited
25/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes