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Trial record 45 of 242 for:    furosemide

Metabolic Effects of Furosemide +HSS in Refractory Ascites

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ClinicalTrials.gov Identifier: NCT02821377
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Antonino Tuttolomondo, University of Palermo

Brief 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.


Condition or disease Intervention/treatment Phase
Ascites Cirrhosis Drug: intravenous furosemide Drug: Hypertonic saline solutions Procedure: Seriated paracentesis Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immune-inflammatory and Metabolic Effects of High Dose Furosemide Plus Hypertonic Saline Solution (HSS) Treatment in Cirrhotic Subjects With Refractory Ascite
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: intravenous furosemide
intravenous infusion of furosemide (doses 125-250mg⁄ bid) from the first day after admission until 3 days before discharge Intervention: drug: furosemide ; other name: lasix
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.
Other Name: furosemide +HSS

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.
Other Name: HSS

Experimental: intravenous hypertonic saline solutions
small volumes of hypertonic saline solutions (HSS) (150mL 1.4-4.6% NaCl), from the first day after admission until 3 days before discharge Intervention: Hypertonic saline solutions (1.4-4.6%NaCl) Intervention other name: not specified
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.
Other Name: furosemide +HSS

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.
Other Name: HSS

Active Comparator: seriated paracentesis
no intervention Intervention: no drug only seriated paracentesis repeated paracentesis from the first day after admission until 3 days before discharge
Procedure: Seriated paracentesis
repeated paracentesis from the first day after admission until 3 days before discharge
Other Name: paracentesis




Primary Outcome Measures :
  1. Δ-ANP [ Time Frame: 8 days ]
    difference between ANP serum levels at admission and ANP serum levels at discharge.


Secondary Outcome Measures :
  1. Δ-BNP (pg/ml): evaluated by means of the difference between BNP plasma levels at admission and BNP plasma levels at discharge. [ Time Frame: 8 days ]
    difference between BNP serum levels at admission and BNP serum levels at discharge.

  2. Δ IL-1beta (pg/ml): evaluated by means of the difference between IL-1beta plasma levels at admission and IL-1beta plasma levels at discharge. [ Time Frame: 8 days ]
    difference between IL-1 beta serum levels at admission and IL-1 beta serum levels

  3. Δ-visfatin (ng/ml): evaluated by means of the difference between serum visfatin at admission and serum visfatin at discharge. [ Time Frame: 8 days ]
    difference between serum visfatin at admission and serum visfatin at discharge.

  4. Δ-Leptin (ng/ml): evaluated by means of the difference between serum leptin at admission and serum leptin at discharge. [ Time Frame: 8 days ]
    difference between serum leptin at admission and serum leptin at discharge.

  5. Δ-TNF-alfa (ng/ml): evaluated by means of the difference between serum TNF-alfa at admission and serum TNF-alfa discharge. [ Time Frame: 8 days ]
    difference between serum TNF-alfa at admission and serum TNF-alfa at discharge.

  6. Δ-TNF-alfa (ng/ml): evaluated by means of the difference between serum IL-6 at admission and serum IL-6 at discharge. [ Time Frame: 8 days ]
    difference between serum IL-6 at admission and serum Il-6 at discharge.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821377


Locations
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Italy
Antonino Tuttolomondo
Palermo, Italy, 90127
Internal Medicine Ward of Palermo University Hospital
Palermo, Italy, 90127
Internal Medicine Ward, University of Palermo
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
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Study Chair: Antonio Pinto, MD University of Palermo

Publications:
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Responsible Party: Antonino Tuttolomondo, MD, PhD, Associate Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT02821377     History of Changes
Other Study ID Numbers: 21771
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Antonino Tuttolomondo, University of Palermo:
cirrhosis
ascites
immunology
inflammation
nutrition
Additional relevant MeSH terms:
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Furosemide
Fibrosis
Ascites
Pathologic Processes
Pharmaceutical Solutions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action