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Metabolic Effects of Furosemide +HSS in Refractory Ascites

NCT02821377 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-07-01

No results posted yet for this study

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.

Conditions

  • Ascites
  • Cirrhosis

Interventions

DRUG

intravenous furosemide

treatment with intravenous infusion of furosemide (doses 125-250mg⁄ bid) plus small volumes of HSS (150mL 1.4-4.6% NaCl), from the first day after admission until 3 days before discharge, with water restriction and a normal sodium diet.

DRUG

Hypertonic saline solutions

Intravenous small volumes of HSS (150mL 1.4-4.6% NaCl), plus treatment with intravenous infusion of furosemide (doses 125-250mg⁄ bid) from the first day after admission until 3 days before discharge, with water restriction and a normal sodium diet.

PROCEDURE

Seriated paracentesis

repeated paracentesis from the first day after admission until 3 days before discharge

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Antonio Pinto, MD · University of Palermo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02821377 on ClinicalTrials.gov