The trial enrolled 83 adults with cirrhosis and septic shock across three European hospitals. Patients received either hydrocortisone or placebo, in addition to standard treatment.

After 28 days, mortality rates were similar in both groups (35% in the hydrocortisone-treated group vs. 39.5% in the placebo group). Hydrocortisone did not improve overall shock resolution or reduced the risk of shock relapse, although fewer patients in the hydrocortisone group died specifically from refractory shock — a persistent lack of response to vasopressors. Some adverse events, particularly hypo- and hyperglycemia, were more frequent in patients receiving hydrocortisone. Rates of infections (bacterial, cytomegalovirus, or fungal), gastrointestinal bleeding, and organ system failures were similar in both groups.

The SCOTCH trial shows that hydrocortisone should not be used as routine therapy for patients with cirrhosis and septic shock requiring low to moderate doses of vasopressors. 

Importantly, the study found that the main predictors of survival were the severity of liver disease, the presence of acute-on-chronic liver failure (ACLF), and whether patients received adequate early antibiotic therapy. These factors outweighed the impact of hydrocortisone on outcomes.

“Rapid and appropriate antimicrobial treatment, careful assessment of ACLF severity, and timely consideration of liver transplantation remain the cornerstones of care in patients with cirrhosis and septic shock”, said Javier Fernández, Head of the Intensive Care Unit at Hospital Clínic de Barcelona, researcher at Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), and Head of Clinical Operations at EF CLIF.

Because the trial terminated earlier than planned, the findings on steroid therapy remain inconclusive. Only a small proportion of patients had severe septic shock requiring high doses of vasopressors, a group in which hydrocortisone could still prove useful. Larger studies are needed to determine its potential benefit in patients with refractory shock. “Although this study was not conclusive, it revealed the main prognostic determinants in patients with cirrhosis and septic shock, many of them clearly addressable, added Fernández. “Despite the limitations, SCOTCH provides an essential stepping stone for current clinical management of patients with cirrhosis and septic shock”, he concluded.

The SCOTCH study (NCT02602210) was sponsored by Universitaire Ziekenhuizen KU Leuven, Belgium, and funded by the European Foundation for the Study of Chronic Liver Failure (EF CLIF), Spain.

Javier Fernández is supported by Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Spain.

Other authors in the study are Philippe Meersseman, María Hernández-Tejero, Juan Manuel Diaz, Joost Wauters, Greet Hermans, Fátima Aziz, Helga Ceunen, Veronica Prado, Lies Langouche, Mireya Arteaga, Juan Acevedo, Marc Lleixa, Juliana Zapatero, David Toapanta, Vicente Arroyo, and Alexander Wilmer.