Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144713
• Other study ID #: ILBS-Cirrhosis-10
• Status: Completed
• Phase: N/A
• Start date: May 28, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Terlipressin
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)
• Midodrine
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
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).		Day 6
Secondary	Number of hospital admission withing 28 days in all the 3 groups		28 days
Secondary	Development of Hyponatremia in all the 3 groups	Hyponatremia is defined as S.Na < 130 meq/dL.	Day 28
Secondary	Development of Hepatic Encephalopathy in all the 3 groups	Hepatic Encephalopathy defined as West Haven Grade > 1	Day 28
Secondary	Recurrence of ascites in all the 3 groups		Day 28
Secondary	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	Day 28
Secondary	Survival in all the 3 groups		Day 28