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Completed

NCT Number: NCT01637454

TYPE 2 HEPATORENAL SYNDROME

Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS

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Key information

Conditions

Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Postgraduate Institute of Medical Education and Research Chandigarh

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
  • Absence of shock, fluid losses and treatment with nephrotoxic drug
  • No improvement in renal function following diuretic withdrawal and plasma volume expansion
  • No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour

Exclusion criteria

  • Patients with history of coronary artery disease
  • Cardiomyopathy
  • Ventricular arrhythmia
  • Obstructive arterial disease of limbs -

Treatment and study plan

Noradrenaline

Drug

Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour

Terlipressin

Drug

Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour

Primary outcomes

  1. The primary end point of the study was serum creatinine less than 1.5 mg

    Time frame: 15 days

Secondary outcomes

  1. Secondary end points include death of patients

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY

Acronym: Type2 HRS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2012
Registry last updated
Jul 11, 2012

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.