Status:
COMPLETED
Terlipressin in Septic Shock in Cirrhosis
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Liver Cirrhosis
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 cau...
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-adrene...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years;
- Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;
- 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
- More than 24 hours of evolution of the shock;
- Cardiac index \< 2,5 l/min;
- History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;
- Pregnancy;
- Advanced hepatocellular carcinoma (Milan criteria);
- Previous history of transplantation;
- Uncontrolled gastrointestinal bleeding.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00628160
Start Date
October 1 2006
End Date
December 1 2012
Last Update
February 24 2016
Active Locations (1)
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1
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036