Midodrine and Albumin in Patients With Refractory Ascites

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Unknown; Phase 3

Conditions: Refractory Ascites

Treatments: Drug: Albumin; Drug: Midodrine; Drug: Standard medical therapy (SMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04621617

IEC-06/2020-1691

Details and patient eligibility

About

Refractory ascites is seen in 5-10% of patients with cirrhosis.Decompensated cirrhosis with refractory ascites has a mortality rate of around 40% in a year and a median survival of 6 months.Portal hypertension and splanchnic vasodilation are major factors in the development of ascites.The treatment of refractory ascites involves salt restriction, diuretics, large volume paracentesis (LVP), transjugular Intrahepatic Portosystemic shunt (TIPS) and Liver Transplantation (LT). Currently the only curative treatment is LT. However, LT is limited due to organ shortage and high cost.

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 80 years
2. Refractory ascites in cirrhosis of any etiology

Exclusion criteria

1. Mixed ascites: cirrhosis plus another cause of ascites
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups, including a placebo group

Albumin + Midodrine + SMT

Active Comparator group

Description:

Human albumin plus oral midodrine

Treatment:

Drug: Standard medical therapy (SMT)

Drug: Albumin

Drug: Midodrine

Albumin + SMT

Active Comparator group

Description:

Human albumin plus placebo of midodrine

Treatment:

Drug: Standard medical therapy (SMT)

Drug: Albumin

SMT

Placebo Comparator group

Description:

standard medical therapy plus placebo of midodrine

Treatment:

Drug: Standard medical therapy (SMT)