drugset / Trial / NCT00628160

Terlipressin in Septic Shock in Cirrhosis

NCT00628160

Phase 2/3 Completed 72 enrolled Hospital Clinic of Barcelona
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-10
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Terlipressin Peptide 2 mg Intravenous
Subject Terlipressin Peptide 12 mg Intravenous
Comparator Dopamine Small molecule 1 ug/kg
Comparator Dopamine Small molecule 20 ug/kg
Comparator Norepinephrine Other / unclassified 0.05 ug/kg
Comparator Norepinephrine Other / unclassified 4 ug/kg