SCOTCHIS trial
Research type
Research Study
Full title
Supplemental COrTicosteroids in Cirrhotic Hypotensive patients with suspicion of SepsIS. The SCOTCHIS trial
IRAS ID
207950
Contact name
Juan Acevedo
Contact email
Sponsor organisation
University Hospitals of Leuven
Eudract number
2010-024273-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Septic shock in patients with liver cirrhosis has high mortality. There are a few studies suggesting that use of hydrocortisone improves survival. But, other trial showed no difference in survival. In view of contradictory data it is important to assess the efficacy of hydrocortisone in improving survival in this setting.
The areas studied are liver cirrhosis and infectious disease (septic shock). The drug tested is intravenous hydrocortisone. Participants will be randomly allocated to intravenous hydrocortisone or placebo.
356 adult patients admitted to ITU with liver cirrhosis and septic shock will be included in total. Patients with important comorbidities such as HIV infection, shock of cardiac origin, severe chronic pulmonary or cardiac disease, known hypoadrenalism, very advanced liver disease or very high score of severity of critically-ill disease, and those with contraindications to receive hydrocortisone will be excluded.
Multiple sites across United Kingdom and Europe with high standards of care in liver disease, counting with a team of intensivists or equivalent physicians (hepatologists, gastroenterologists, or internist) involved in the care of patients with liver disease in the ICU, 24 hours per day and 7 days per week; and with a department of Hepatology with 24 hour consultancy for a hepatologist and involved in research in the field of liver failure participate in this study.
Active treatment consists of an intravenous bolus of 100mg of hydrocortisone followed by a continuous intravenous infusion of 8mg per hour of hydrocortisone for a maximum of 10 days. Blood samples will be taken at day 0, 7 and at discharge from ITU. Urinary samples will be collected during the first 7 days. Collection of data will last until the patient is discharged from hospital.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0503
Date of REC Opinion
8 Mar 2017
REC opinion
Further Information Favourable Opinion