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Aim of the Study

We plan to perform a double-blind, randomized, placebo-controlled multicentre trial to elucidate the efficacy of treating hypotensive cirrhotic patients on vasopressors with low-dose corticosteroids. The main goal of the study is to investigate the clinical impact, efficacy and safety of treating hypotensive cirrhotic patients on vasopressors with low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to decrease mortality.

Study type and primary goal

This study will be a double-blind, randomized, placebo-controlled, parallel-group, multicentre trial, involving tertiary intensive care units with expertise in management of patients with decompensated cirrhosis.

Patients who satisfy inclusion criteria and do not present any of the exclusion criteria at ICU admission will be randomized into two groups:

>>Group A: treated with intravenous hydrocortisone in addition to standard therapy (= treatment group)

>>Group B: placebo treatment in addition to standard treatment (= placebo group)

Regarding the primary objetive:

To determine whether low doses of hydrocortisone improves the 28-day mortality when added to the standard management of cirrhotic patients with vasopressor dependent shock and suspicion of active infection.

Secondary goals

To determine whether stress doses of hydrocortisone:

- improve the ICU, hospital and 90-day mortality
- shorten the time to resolution of shock and reversal of organ failure
- shorten the length of stay in ICU for ICU survivors and the length of stay in hospital for hospital survivors
- reduce the frequency of new organ failure
- are associated with shock relapse
- are associated with the development of new infection episodes or development of infections caused by resistant bacteria, viruses or fungi
- are associated with the development of adverse events related to major bleeding complications and coagulation disturbances
- are associated with severe hyperglycemia
- are associated with the development of ICU acquired weakness.

• To estimate the incidence of CIRCI in hypotensive cirrhotic patients on vasopressors according to the proposed definition.
• To identify and characterize those who benefit most from corticosteroid therapy
• To evaluate the diagnostic and prognostic value of the Synacthentest in the selection of patients for treatment with steroids.
• To establish the diagnostic criteria and propose a better definition for cirrhosis related corticosteroid insufficiency
• To try to elucidate the pathophysiology of adrenal insufficiency in cirrhotic patients