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Completed

NCT Number: NCT03144713

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

* 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)

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cirrhosis who undergo Large volume paracentesis (> 5L)
  • Patients with age from 18-75 years

Exclusion criteria

  • Renal failure ( Creatinine>1.5mg/dl)
  • Recent Gastrointestinal bleeding within 7 days
  • Spontaneous bacterial Peritonitis
  • Patients with Cardiovascular disease (Electrocardiogram, 2D Echo)
  • Systemic arterial hypertension ( >160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
  • Patients with active untreated sepsis
  • Pregnancy
  • Patients with hepatic encephalopathy
  • No use of drugs affecting systemic hemodynamic 3 days prior to enrollment
  • Refusal to participate

Treatment and study plan

Terlipressin

Drug

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

Drug

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

Drug

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

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

    Time frame: Day 28

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

  3. Development of Hepatic Encephalopathy in all the 3 groups

    Time frame: Day 28

    Hepatic Encephalopathy defined as West Haven Grade > 1

  4. Recurrence of ascites in all the 3 groups

    Time frame: Day 28

  5. Development of Acute Kidney Injury in all the 3 groups

    Time frame: Day 28

    Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL

  6. Survival in all the 3 groups

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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