* 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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)
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)
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
Time frame: Day 6
Number of hospital admission withing 28 days in all the 3 groups
Time frame: 28 days
Development of Hyponatremia in all the 3 groups
Hyponatremia is defined as S.Na \< 130 meq/dL.
Time frame: Day 28
Development of Hepatic Encephalopathy in all the 3 groups
Hepatic Encephalopathy defined as West Haven Grade \> 1
Time frame: Day 28
Recurrence of ascites in all the 3 groups
Time frame: Day 28
Development of Acute Kidney Injury in all the 3 groups
Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL
Time frame: Day 28
Survival in all the 3 groups
Time frame: Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.