Terlipressin in Septic Shock in Cirrhosis
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|ClinicalTrials.gov Identifier: NCT00628160|
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : February 24, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Septic Shock||Drug: Terlipressin Drug: alpha adrenergic drugs||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
- Hospital survival [ Time Frame: Hospitalization ]
- Refractory shock [ Time Frame: ICU admission ]
- Variceal bleeding [ Time Frame: ICU admission ]
- Hepatorenal syndrome [ Time Frame: Hospitalization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|