Metabolic Effects of Furosemide +HSS in Refractory Ascites

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Palermo
• Treatments: Furosemide; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Refractory ascites defined according to the International Ascites Club criteria

Exclusion Criteria:

• inability to obtain informed consent

• possible non-cirrhotic ascites

• congestive heart failure (defined by clinical exam and echocardiogram)

• acute renal failure

• hepatocellular carcinoma based on the Barcelona Clinic liver Cancer (BCLC) criteria

• complete portal vein thrombosis, active sepsis or other incurable cancers