Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Midodrine+SMT: Start orally with 5 mg TDS. Increase 2.5 mg every day with target MAP increase of 10 mmHg, maximum upto 15 mg TDS.SMT
Control Intervention1: SMT+Placebo: Placebo will be
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than equals to 18 years. 2. ACLF 3. Ascites (Grade II/III). 4. Willing/able for salt restriction, labs, urine collections, and follow-ups; consent obtained.
Exclusion criteria
Exclusion criteria: 1. SCr more than equals to 1.5 mg per dL OR ongoing AKI more than stage I 2. Persistent or uncorrectable severe hyponatremia (Na, less than equals to 120 mEq per L), hyperkalemia (more than 6.0 mEq per L) or any other critical electrolyte imbalance. 3. Refractory ascites 4. Spontaneous bacterial peritonitis 5. Hepatic encephalopathy grade II or III. 6. Shock, need for IV vasopressors, SBP less than equals to 90 mmHg or MAP less than equals to 65 despite fluidsper albumin. 7. Active GI bleed, uncontrolled infection or sepsis, or SBP at screening. 8. Severe cardiomyopathy, critical valvular disease, arrhythmias contraindicating alpha-agonists. 9. ACLF patients on Mechanical ventilation or ICU or ionotropes or High flow oxygen 10. Pregnancy, lactation. 11. Hypersensitivity or intolerance to midodrine. 12. Significant LUTS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare ascites resolution rates (complete response) between the two groups at day 28.Timepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete ascites response.Timepoint: 7,14 days;Partial ascites response, Change in MAP/HR/Weight change/Urine output dailyTimepoint: 7,14,28 days;Absent response or worsening of ascites,Mortality,New onset AKI, SBP, HE, Hyponatremia, shock and need for MV, Treatment related adverse effects,& Cumulative dose of diuretics/Albumin/midodrine/carvedilol.Timepoint: Day 28;LVP requirement in two groupsTimepoint: 7,28 day;Intra Abdominal pressure,Timepoint: baseline and day 7;Change in urine NaTimepoint: day 3, 7 and 28 from baseline;Change in MELD score, AARC score .Timepoint: day 4, 7 and 28;Change in HVPG.Timepoint: baseline, 14 and 28 days. | — |
Countries
India
Contacts
Public ContactDr Ankur jindal
Institute of Liver and Biliary Sciences
Outcome results
None listed