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CompletedNCT03144713Updated Sep 5, 2018

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

An interventional study of Terlipressin and Midodrine in Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Cirrhosis
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 150 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    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)

    Drug: Terlipressin

  • Active comparator
    Midodrine

    Midodrine 7.5 mg thrice daily for 3 days.

    Drug: Midodrine

  • Active comparator
    Standard Medical Therapy

    Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

    Drug: Albumin

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.

06

What researchers measure

Primary outcomes

  1. Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).

    Time frame: Day 6

Secondary outcomes

  1. Number of hospital admission withing 28 days in all the 3 groups

    Time frame: 28 days

  2. Development of Hyponatremia in all the 3 groups

    Hyponatremia is defined as S.Na \< 130 meq/dL.

    Time frame: Day 28

  3. Development of Hepatic Encephalopathy in all the 3 groups

    Hepatic Encephalopathy defined as West Haven Grade \> 1

    Time frame: Day 28

  4. Recurrence of ascites in all the 3 groups

    Time frame: Day 28

  5. 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

  6. Survival in all the 3 groups

    Time frame: Day 28

07

Study locations

1 site
  • Institute of Liver and Biliary Sciences
    New Delhi, Delhi 110070, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03144713
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
May 9, 2017
Start date
May 28, 2017
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Last update
Sep 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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