Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Hospital Clinic of Barcelona

Status and phase: Suspended; Phase 4

Conditions: Cirrhosis; Hepatorenal Syndrome

Treatments: Drug: terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT00287664

TAHRS

Details and patient eligibility

About

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.

Full description

Phase 3

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)