Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome

University of Padova

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Cirrhosis; Hepatorenal Syndrome

Treatments: Drug: Midodrine plus octreotide plus human albumin; Drug: Terlipressin plus albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT00742339

1264P

Details and patient eligibility

About

From 1999, several studies have showed that the use of vasoconstrictors in association with albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the use of vasoconstrictors together with albumin in the treatment of this severe complication of portal hypertension in patients with cirrhosis is to correct the reduction of the effective circulating volume due to the splanchnic arterial vasodilatation.In most of these studies terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr. In some studies midodrine, an alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon, given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. To the day, there isn't a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the treatment of HRS in patients with cirrhosis.Thus, the aim of the study is to compare terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the HRS in patients with cirrhosis.

Enrollment: 49 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cirrhosis and diagnosis of HRS type 1 or 2,serum creatinine > 2.5 mg/dl

Exclusion criteria

• Diagnosis of HCC with a staging beyond the Milan Criteria di Milano
• Septic shock (systolic arterial pressure < 90 mmHg
• Significant heart or respiratory failure
• Peripheral arteriophaty clinically significant
• Previous heart stroke or significant alteration of the ECG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

1

Active Comparator group

Description:

Fifty patients with cirrhosis and HRS will be randomly assigned to arm 1.

Treatment:

Drug: Terlipressin plus albumin

2

Experimental group

Description:

Fifty patients with cirrhosis and HRS will be randomly assigned to arm 2.

Treatment:

Drug: Midodrine plus octreotide plus human albumin