drugset / Trial / NCT02821377

Metabolic Effects of Furosemide +HSS in Refractory Ascites

NCT02821377

Phase 2 Completed 40 enrolled University of Palermo
RandomizedParallel-groupOpen-labelTreatment

Summary

Introduction: Patients with chronic liver diseases are usually thin as a result of hypermetabolism and malnutrition expressed by reduced levels of leptin and impairment of other adyponectins such as visfatin. Aims: To evaluate the metabolic and inflammatory effects of intravenous high-dose furosemide plus hypertonic saline solutions (HSS) compared with repeated paracentesis and a standard oral diuretic schedule, in patients with cirrhosis and refractory ascites. Methods; All consecutive cirrhotic patients with refractory ascites unresponsive to outpatient treatment will be enrolled . Enrolled subjects will be randomized to treatment with intravenous infusion of furosemide (125-250mg⁄bid) plus small volumes of HSS from the first day after admission until 3 days before discharge (Group A ), or repeated paracentesis from the first day after admission until 3 days before discharge (Group B, ). Plasma levels of ANP, BNP, Leptin, visfatin, IL-1β, TNF-a, IL-6 were measured before and after the two type of treatment.

Timeline

Start
2013-12
Primary completion
2015-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified 125 mg Intravenous
Subject Furosemide Other / unclassified 250 mg Intravenous
Subject Hypertonic saline solutions Unknown 1.4 % Intravenous
Subject Hypertonic saline solutions Unknown 4.6 % Intravenous
Subject Hypertonic saline solutions Unknown 150 ml Intravenous

Indications