se of corticosteroids (ie. adrenal gland hormone) in the treatment of cirrhotic patients with suspected sepsis and low blood pressure compared to placebo

Phase 1

• Conditions: Cirrhotic patients under vasopressors admitted to the ICU because of persisting hypotension and with suspected infection.; Therapeutic area: Not possible to specify

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-03
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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, in both cases despite adequate fluid resuscitation and with need for low-dose norepinephrine, are eligible for study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

•Age < 18 or = 80 years
•Patients receiving any vasopressor medication for more than 24 h prior to administration of study drug
•Patients with known hypoadrenalism
•Active GI bleeding (unless controlled for >72 hours) or hemorrhagic shock.
•Cardiogenic shock or severe cardiac dysfunction (CI <2 l/min/ m2)
•Active uncontrolled hepatitis B infection
•HIV infection
•Evidence of current malignancy (except hepatocellular carcinoma within transplant criteria or non-melanocytic skin cancer)
•Therapy with any corticosteroid in the last 3 months
•Patients who received etomidate within the past 3 days
•Severe acute alcoholic hepatitis (biopsy proven)
•Chronic hemodialysis
•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 > 12 points at inclusion
•Pregnant or breastfeeding women
•Contraindications for systemic steroids
•Refusal to consent

Study & Design

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