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

Phase 2

Terminated

• Conditions: Cirrhosis; Hepatorenal Syndrome
• Interventions: Drug: Terlipressin plus albumin; Drug: Midodrine plus octreotide plus human albumin

• Registration Number: NCT00742339
• Lead Sponsor: University of Padova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-11
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Terlipressin plus albumin	Fifty patients with cirrhosis and HRS will be randomly assigned to arm 1.
2	Midodrine plus octreotide plus human albumin	Fifty patients with cirrhosis and HRS will be randomly assigned to arm 2.

Primary Outcome Measures

Name	Time	Method
The primary end-point of the study is the complete reform of the renal function (serum creatinine < 1.5 mg/dl. The primary end point will be evaluated at the end of the treatment.	The treatment will be continued for a maximum of 15 days

Trial Locations

Locations (1)

Dept. of Clinical and Experimental Medicine, University of Padova; 🇮🇹 Padova, Italy