Midodrine and Albumin in Patients With Refractory Ascites
NCT ID: NCT04621617
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
114 participants
INTERVENTIONAL
2020-11-30
2022-04-30
Brief Summary
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Long-term human albumin (HA) administration in patients with uncomplicated and refractory ascites, has shown to improve survival or delay the complications of cirrhosis. Midodrine, an oral α1- adrenergic agonist has been used in refractory ascites with variable results. However, there is no study on the use of long term Midodrine and HA in patients with refractory ascites. Therefore, we plan to study the effect of long term midodrine and HA in patients with refractory ascites.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Albumin + Midodrine + SMT
Human albumin plus oral midodrine
Albumin
Human albumin will be administered by intravenous infusion at a dose of 1.5 gm/kg/week for 2 weeks followed by HA 40 grams every 7days
Midodrine
Oral Midodrine will be given at a dose of 7.5 mg three times in a day
Standard medical therapy (SMT)
SMT will include nutritional support, rifaximin, lactulose or lactitol, diuretics, SBP prophylaxis with norfloxacin, restriction of sodium, multivitamins, and other supportive measures as deemed necessary. LVP will be done as needed. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.
Albumin + SMT
Human albumin plus placebo of midodrine
Albumin
Human albumin will be administered by intravenous infusion at a dose of 1.5 gm/kg/week for 2 weeks followed by HA 40 grams every 7days
Standard medical therapy (SMT)
SMT will include nutritional support, rifaximin, lactulose or lactitol, diuretics, SBP prophylaxis with norfloxacin, restriction of sodium, multivitamins, and other supportive measures as deemed necessary. LVP will be done as needed. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.
SMT
standard medical therapy plus placebo of midodrine
Standard medical therapy (SMT)
SMT will include nutritional support, rifaximin, lactulose or lactitol, diuretics, SBP prophylaxis with norfloxacin, restriction of sodium, multivitamins, and other supportive measures as deemed necessary. LVP will be done as needed. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.
Interventions
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Albumin
Human albumin will be administered by intravenous infusion at a dose of 1.5 gm/kg/week for 2 weeks followed by HA 40 grams every 7days
Midodrine
Oral Midodrine will be given at a dose of 7.5 mg three times in a day
Standard medical therapy (SMT)
SMT will include nutritional support, rifaximin, lactulose or lactitol, diuretics, SBP prophylaxis with norfloxacin, restriction of sodium, multivitamins, and other supportive measures as deemed necessary. LVP will be done as needed. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.
Eligibility Criteria
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Inclusion Criteria
2. Refractory ascites in cirrhosis of any etiology
Exclusion Criteria
2. Gastrointestinal bleed within 7 days of enrolment.
3. Presence of hepatorenal syndrome
4. Hepatic encephalopathy grade 2 or higher
5. Infection within 1 month preceding the study
6. Cardiovascular disease (ejection fraction \< 35% or abnormal ECG) or arterial hypertension (BP \> 140/90 mm of Hg)
7. Abnormal urine analysis with proteinuria \> 500 mg/24 hour or 50 red blood cells/high power field, or granular casts or ultrasonographic evidence of intrinsic renal disease
8. Presence of hepatocellular carcinoma or portal vein thrombosis
9. Treatment with drug with known effects on systemic and renal hemodynamics within 7 days of inclusion excepting beta-blockers
10. Patient not willing for study.
11. Patient opting for liver transplantation/ transjugular intrahepatic portosystemic shunt
18 Years
80 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Dr.Virendra Singh
Professor and Head, Department of Hepatology
Principal Investigators
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Virendra Singh, MD, DM
Role: PRINCIPAL_INVESTIGATOR
PGIMER, Chandigarh
Central Contacts
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Other Identifiers
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IEC-06/2020-1691
Identifier Type: -
Identifier Source: org_study_id