Terlipressin in Septic Shock in Cirrhosis
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.
|Liver Cirrhosis Septic Shock||Drug: Terlipressin Drug: alpha adrenergic drugs||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial|
- Hospital survival [ Time Frame: Hospitalization ]
- Refractory shock [ Time Frame: ICU admission ]
- Variceal bleeding [ Time Frame: ICU admission ]
- Hepatorenal syndrome [ Time Frame: Hospitalization ]
|Study Start Date:||October 2006|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Terlipressin group
Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
Other Name: Glypressin
Active Comparator: Control group
Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
Drug: alpha adrenergic drugs
Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
Other Name: Dopamine and/or norepinephrine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628160
|Hospital Clinic Barcelona|
|Barcelona, Catalonia, Spain, 08036|
|Principal Investigator:||Javier Fernandez, MD||Hospital Clinic of Barcelona|
|Study Director:||Vicente Arroyo, MD||Hospital Clinic of Barcelona|