Terlipressin in Septic Shock in Cirrhosis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal bleeding are the main causes of death of these patients. Terlipressin administration could prevent these complications and improve survival in this setting.

Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic patients with severe sepsis or septic shock.

Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with severe sepsis or septic shock who will be randomized to receive terlipressin plus alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo). Changes in vasoactive systems and cytokines levels will be also evaluated.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Adrenergic Agents; Dopamine; Dopamine Agents; Lypressin; Norepinephrine; Terlipressin

Criteria

Inclusion Criteria:

1. Age between 18 and 80 years;

2. Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;

3. Diagnosis of septic shock based on the presence of data compatible with systemic inflammatory response syndrome, a mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation, and need for circulatory support with vasopressor drugs.

Exclusion Criteria:

1. More than 24 hours of evolution of the shock;

2. Cardiac index < 2,5 l/min;

3. History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;

4. Pregnancy;

5. Advanced hepatocellular carcinoma (Milan criteria);

6. Previous history of transplantation;

7. Uncontrolled gastrointestinal bleeding.