Terlipressin in Septic Shock in Cirrhosis

Phase 2

Completed

• Conditions: Liver Cirrhosis; Septic Shock
• Interventions: Drug: alpha adrenergic drugs; Drug: Terlipressin

• Registration Number: NCT00628160
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

Detailed Description

Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis. Impact of terlipressin administration on shock reversal, changes in vasoactive systems, inflammatory response, incidence of variceal bleeding and type-1 HRS and ICU and hospital mortality was investigated

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-03-03
• Study First Posted: 2008-03-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group	alpha adrenergic drugs	Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
Terlipressin group	Terlipressin	Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)

Primary Outcome Measures

Name	Time	Method
Hospital survival	Hospitalization

Secondary Outcome Measures

Name	Time	Method
Refractory shock	ICU admission
Variceal bleeding	ICU admission
Hepatorenal syndrome	Hospitalization

Trial Locations

Locations (1)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Catalonia, Spain