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Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites

NCT04785755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-03-08

No results posted yet for this study

Summary

This work aimed to evaluate and compare the impact of adding hypertonic saline solution (HSS) infusion and/or etilefrine to oral diuretics therapy on clinical outcomes, renal and systemic hemodynamics, metabolic and inflammatory pathways by estimating the changes in selected biological markers in cirrhotic patients with ascites. Also, the trial aims to assess the safety and tolerability of such treatment regimens.

Conditions

  • Hepatic Ascites

Interventions

DRUG

Oral standard diuretics therapy

Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).

DRUG

Hypertonic saline solution

Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.

DRUG

Etilefrine

Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).

Sponsors & Collaborators

  • Hala Abd EL-Tawab Ibrahim Radwan

    lead OTHER

Principal Investigators

  • Gamal A Badra, professor · national liver institute / menoufiya university

  • Sahar El-Haggar, professor · Tanta University

  • hala El said, professor · national liver institute / menoufiya university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2020-03-21
Completion
2020-04-30

Countries

  • Egypt

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 NCT04785755 on ClinicalTrials.gov