Efficacy of treatment with steroids in patients with liver cirrhosis and septic shock

Phase 1

• Conditions: Cirrhotic patients under vasopressors admitted to the Intensive Care Unit (ICU) because of persisting hypotension and with suspected infection.; MedDRA version: 20.0 Level: LLT Classification code 10020518 Term: Hydrocortisone System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-024273-38-GB
• Lead Sponsor: niversity Hospitals of Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 356

Inclusion Criteria

All patients with known or recently diagnosed cirrhosis who
a) are admitted to the ICU because of persistent hypotension or
b) develop persistent hypotension while admitted to the ICU,
both secondary to proven or suspected infection, in both cases despite adequate fluid resuscitation and with need of norepinephrine (any dose) to maintain a mean arterial blood pressure > 60 mmHg or > 65 mmHg if accompanied with signs of organ hypoperfusion, are eligible for study entry. The diagnosis of cirrhosis is preferably made by histology or based on imaging and laboratory findings.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 339
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

•Age < 18
•Patients receiving any vasopressor medication, initiated for septic shock, for more than 24 h prior to administration of study drug. Terlipressin initiated for treatment of hepatorenal syndrome or variceal bleeding is allowed.
•Patients with known hypoadrenalism
•Active GI bleeding (unless controlled for > 24 hours) or haemorrhagic shock.
•Cardiogenic shock or severe cardiac dysfunction (CI <2 l/min/ m2)
•Active uncontrolled hepatitis B infection
•HIV infection
•Evidence of advanced malignancy (except hepatocellular carcinoma within transplant criteria or non-melanocytic skin cancer). Malignancies in remission are allowed (for example: small cholangiocarcinomas treated and in theoretical response or breast and prostatic cancers in remission).
•Therapy with any corticosteroid (oral or intravenous) in the last 3 months
•Therapy with any other immunosuppressive drug in the last 3 months
•Patients who received etomidate within the past 3 days
•Severe acute alcoholic hepatitis (biopsy proven), because it compromises the survival
•Chronic haemodialysis
•Severe chronic heart disease (NYHA class III or IV)
•Severe chronic obstructive pulmonary disease (GOLD III or IV)
•Severe psychiatric disorder
•Child-Pugh score C14 -15
•SOFA score > 16 points at inclusion (SOFA is a score of severity of critically ill disease according to number and degree of organ failure)
•Pregnant or breastfeeding women
•Contraindications for systemic steroids
•Refusal to consent
•Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified