Status:
SUSPENDED
Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Grant from Education Ministery from 2001-2004.
Conditions:
Cirrhosis
Hepatorenal Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin...
Detailed Description
Phase 3
Eligibility Criteria
Inclusion
- Patients with HRS type 1 or 2 with serum creatinine \>2 mg/dL
- Age between 18 and 75 years
- Written informed consent.
- Absence of exclusion criteria
Exclusion
- Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule \> than 5 cm)
- Active infection with systemic inflammatory response syndrome
- Respiratory or cardiac dysfunction.
- Arteriopathy.
- Ischemic cardiopathy.
- Arterial hypertension ( \>140/90 mmHg during hospitalization )
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00287664
Start Date
February 1 2002
End Date
September 1 2006
Last Update
April 11 2007
Active Locations (1)
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1
Hospital Clinic
Barcelona, Barcelona, Spain, 08036