At a glance
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Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Egyptian Cirrhotic Patients With Ascites
In Brief
A Phase 2 clinical trial evaluating Oral standard diuretics therapy, Hypertonic saline solution, and 1 other intervention for Hepatic Ascites. Completed, enrolled 90 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
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.
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).