An interventional study of Midodrine 2.5 mg tab in Refractory Ascites and Children, Only, sponsored by National Liver Institute, Egypt. Status unknown at 1 site in Egypt. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by National Liver Institute, Egypt · Not applicable, Interventional, and Treatment
Ascites in liver cirrhosis is explained by increased production of vasoactive substances leading to renal vasoconstriction and salt and water retention. The retained water then accumulates in the peritoneal cavity under the effect of portal hypertension and low albumin. Refractory ascites is defined as ascites that cannot be mobilized or prevented from early recurrence after large-volume paracentesis despite medical therapy and dietary sodium restriction. Midodrine is an α1 receptor agonist that can improve systemic and renal hemodynamics in non-azotemic cirrhotic patients by counteracting mesenteric vasodilatation, which is accentuated in cirrhosis.
Ascites in liver cirrhosis is explained by increased production of vasoactive substances, such as nitric oxide, carbon monoxide, and endocannabinoids, which cause splanchnic vasodilatation, increased blood flow through this area, and a decrease in peripheral vascular resistance and the effective arterial volume with resulting reduction in renal blood flow with subsequent activation of rennin-angiotensin-aldosterone system which in turn leads to renal vasoconstriction and salt and water retention. The retained water then accumulates in the peritoneal cavity under the effect of portal hypertension and low albumin.
The International Ascites Club defines refractory ascites as ascites that cannot be mobilized or prevented from early recurrence after large-volume paracentesis despite medical therapy and dietary sodium restriction.
There are two varieties of refractory ascites: diuretic-resistant ascites that is unresponsive to the maximal tolerable dose of diuretic therapy and diuretic-intractable ascites when complications such as hepatic encephalopathy, renal dysfunction, or electrolyte abnormalities limit the use of diuretics in the effective therapeutic dose (Cárdenas and Arroyo, 2005)
The therapeutic options for refractory ascites are serial therapeutic paracentesis, transjugular intrahepatic portosystemic shunt, peritoneovenous shunt, and liver transplantation.
Midodrine is transformed into the active metabolite desglymidodrine, which is an α1 receptor agonist causing an increase in vascular tone and increase in blood pressure without β-adrenergic receptors stimulation so, it can improve systemic and renal hemodynamics in non-azotemic cirrhotic patients by counteracting mesenteric vasodilatation, which is accentuated in cirrhosis. It diffuses poorly across the blood-brain barrier with no central effects.
In a study included 600 adult patients with refractory ascites, midodrine was added to diuretic therapy and lead to enhancement of diuresis with the improvement of systemic, renal hemodynamics and short-term survival. Approximately, the only use of midodrine hydrochloride in children was in postural orthostatic tachycardia syndrome (POTS) which showed a good efficacy and safety profile.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's planned enrollment of 20 is below the median of 55 across 177 interventional studies indexed under Ascites.
Browse Ascites studies →National Liver Institute, Egypt is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Midodrine hydrochloride 2.5 mg tab once per day
Drug: Midodrine 2.5 mg tab
Patients receive an oral daily dose of 2.5 mg midodrine if age 7-12 years and receive 2.5 mg twice daily of more than 12 years
Also known as: ProAmatine
Side effect no 1
number of patients with Elevated BP: ≥90th percentile to \<95th percentile
Time frame: 3 months
Side effect no 2
number of patients with Stage 1 HTN: ≥95th percentile to \<95th percentile + 12 mmHg or 130/80 to 139/89 mm Hg (whichever is lower)
Time frame: 3 months
Side effect no 3
number of patients with Stage 2 HTN: ≥95th percentile + 12 mm Hg or ≥140/90 mm Hg (whichever is lower) mmHg or 130/80 to 139/89 mm Hg (whichever is lower)
Time frame: 3 months
Side effect no 4
number of patients with low heart rate
Time frame: 3 months
Side effect no 5
number of patients with urine retention
Time frame: 3 months
Side effect no 6
number of patients with severe itching
Time frame: 3 months
Side effect no 7
number of patients with skin rash
Time frame: 3 months
Complete Response
absence of ascites by abdominal ultrasound
Time frame: 12 months
Partial response
ascites cannot be mobilized completely but not symptomatic or needs paracentesis
Time frame: 12 months
non-response
no decrease in ascites which still in need for paracentesis after 3 months of duration
Time frame: 3 months
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Liver Institute, Egypt