Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Phase 4

Suspended

• Conditions: Cirrhosis; Hepatorenal Syndrome

• Registration Number: NCT00287664
• Lead Sponsor: Hospital Clinic of Barcelona

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 are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

Detailed Description

Phase 3

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Study Completion: 2006-09
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-10
• Last Update Posted: 2007-04-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
2. Age between 18 and 75 years
3. Written informed consent.
4. Absence of exclusion criteria

Exclusion Criteria

1. Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
2. Active infection with systemic inflammatory response syndrome
3. Respiratory or cardiac dysfunction.
4. Arteriopathy.
5. Ischemic cardiopathy.
6. Arterial hypertension ( >140/90 mmHg during hospitalization )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Survival

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain