Supplemental Corticosteroids in Cirrhotic Hypotensive Patients With Suspicion of Sepsis

• Status: Terminated
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of the study is to investigate the clinical relevance, efficacy and safety of treating hypotensive cirrhotic patients with suspicion of sepsis and on vasopressors with low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to decrease mortality.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Antihypertensive Agents; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• All patients with known or recently diagnosed cirrhosis who

1. are admitted to the ICU because of persistent hypotension or

2. develop persistent hypotension while admitted to the ICU,

secondary to proven or suspected infection, in both cases despite adequate fluid resuscitation and with persistent need for low-dose norepinephrine to maintain a mean arterial blood pressure > 60 mmHg or > 65 mmHg if accompanied by signs of hypoperfusion, are eligible for study entry. The diagnosis of cirrhosis is preferably made by histology or based on imaging and laboratory findings.

Exclusion Criteria:

• Age < 18 or ≥ 80 years

• Patients receiving any vasopressor medication 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 >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 (oral or intravenous) 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 > 16 points at inclusion

• 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