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

Information source: University of Padova
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis; Hepatorenal Syndrome

Intervention: Terlipressin plus albumin (Drug); Midodrine plus octreotide plus human albumin (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: University of Padova

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.

Clinical Details

Official title: Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome (HRS): An Open Multicentric Randomized Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Dept. of Clinical and Experimental Medicine, University of Padova, Padova 35100, Italy
Additional Information

Related publications:

Salerno F, Gerbes A, Ginès P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Gut. 2007 Sep;56(9):1310-8. Epub 2007 Mar 27. Review.

Starting date: May 2005
Last updated: October 11, 2014

Page last updated: August 23, 2015

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