Clinical trial NCT03144713: Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
Official title: Randomized Trial Comparing the Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
timeFrame: Day 6
Secondary outcomes:
measure: Number of hospital admission withing 28 days in all the 3 groups
timeFrame: 28 days
measure: Development of Hyponatremia in all the 3 groups
timeFrame: Day 28
measure: Development of Hepatic Encephalopathy in all the 3 groups
timeFrame: Day 28
measure: Recurrence of ascites in all the 3 groups
timeFrame: Day 28
measure: Development of Acute Kidney Injury in all the 3 groups
timeFrame: Day 28
measure: Survival in all the 3 groups
timeFrame: Day 28
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: