Clinical trial NCT00742339: Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome
Official title: Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome (HRS): An Open Multicentric Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cirrhosis
Hepatorenal Syndrome
Keywords: cirrhosis
hepatorenal syndrome
terlipressin
midodrine
octreotide
human albumin
effective circulating volume
The criteria which will be used for the diagnosis of HRS will be the criteria which were recently published by the International Ascites Club
Patients with cirrhosis and type 2 HRS only with serum creatinine value > 2.5 mg/dl
All patients with cirrhosis and type 1 HRS
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: The treatment will be continued for a maximum of 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Dept. of Clinical and Experimental Medicine, University of Padova
Study officials:
References:
citation: Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Gut. 2007 Sep;56(9):1310-8. doi: 10.1136/gut.2006.107789. Epub 2007 Mar 27. No abstract available.