Clinical trial NCT04621617: Midodrine and Albumin in Patients With Refractory Ascites
Official title: Midodrine and Albumin in Patients With Refractory Ascites. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Refractory Ascites
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2020-11-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with control of ascites at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR) measured by modified diet in renal disease 6 (MDRD6) formula at 3 months intervals
timeFrame: 1 year
measure: Changes in concentration of albumin at 3 months intervals
timeFrame: 1 year
measure: Change in model for end stage liver disease (MELD) score
timeFrame: 1 year
measure: Change in mean arterial pressure at 3 months interval
timeFrame: 1 year
measure: Changes in serum and 24- hour urine sodium
timeFrame: 1 year
measure: Incidence of spontaneous bacterial peritonitis (SBP) and other infections
timeFrame: 1 year
measure: Number of patients who develop paracentesis induced circulatory dysfunction (PICD)
timeFrame: 1 year
measure: Number of patients who develop hyponatremia
timeFrame: 1 year
measure: Change in Child-Turcotte-Pugh (CTP) score
timeFrame: 1 year
measure: Number of patients who develop hypokalemia
timeFrame: 1 year
measure: Number of patients who develop hyperkalemia
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: PGIMER, Chandigarh
name: Virendra Singh, MD, DM
role: PRINCIPAL_INVESTIGATOR
References: