Cirrhosis
Conditions
Brief summary
* Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences. * Study Design: Prospective Open Labeled Randomized Controlled Trial. * Study Period: January 2017 to December 2017 * Intervention- Subjects will be randomized to 3 groups * All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only * Monitoring and Assessment: Clinical evaluation will be done at regular intervals. * Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted. * Stopping Rule: Development of PICD, hypertension ( BP\>160/90mmhg-JNC class II)
Interventions
DRUGTerlipressin
Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
DRUGMidodrine
Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
DRUGAlbumin
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with cirrhosis who undergo Large volume paracentesis (\> 5L) 2. Patients with age from 18-75 years
Exclusion criteria
1. Renal failure ( Creatinine\>1.5mg/dl) 2. Recent Gastrointestinal bleeding within 7 days 3. Spontaneous bacterial Peritonitis 4. Patients with Cardiovascular disease (Electrocardiogram, 2D Echo) 5. Systemic arterial hypertension ( \>160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome 6. Patients with active untreated sepsis 7. Pregnancy 8. Patients with hepatic encephalopathy 9. No use of drugs affecting systemic hemodynamic 3 days prior to enrollment 10. Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Paracentesis Induced Circulatory Dysfunction (PICD). | Day 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Hyponatremia in all the 3 groups | Day 28 | Hyponatremia is defined as S.Na \< 130 meq/dL. |
| Development of Hepatic Encephalopathy in all the 3 groups | Day 28 | Hepatic Encephalopathy defined as West Haven Grade \> 1 |
| Number of hospital admission withing 28 days in all the 3 groups | 28 days | — |
| Development of Acute Kidney Injury in all the 3 groups | Day 28 | Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL |
| Survival in all the 3 groups | Day 28 | — |
| Recurrence of ascites in all the 3 groups | Day 28 | — |
Countries
India
Outcome results
None listed