TYPE 2 HEPATORENAL SYNDROME

NCT01637454 | Completed Phase 3

• 1 other identifier: PGIMERIndia
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

noradrenaline terlipressin type 2 HRS

Outcome Measures

Primary Outcomes (1)

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

  15 days

Secondary Outcomes (1)

• Secondary end points include death of patients

  15 days

Study Arms (2)

Terlipressin and Type-2 HRS

ACTIVE COMPARATOR

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.

Drug: Noradrenaline; Drug: Terlipressin

Noradrenaline and Type-2 HRS

ACTIVE COMPARATOR

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

Drug: Noradrenaline; Drug: Terlipressin

Interventions

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

Noradrenaline and Type-2 HRS; Terlipressin and Type-2 HRS

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

Noradrenaline and Type-2 HRS; Terlipressin and Type-2 HRS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (2)

• Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.

  PMID: 17560680 RESULT

• Ghosh S, Choudhary NS, Sharma AK, Singh B, Kumar P, Agarwal R, Sharma N, Bhalla A, Chawla YK, Singh V. Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study. Liver Int. 2013 Sep;33(8):1187-93. doi: 10.1111/liv.12179. Epub 2013 Apr 21.

  PMID: 23601499 DERIVED

MeSH Terms

Interventions

Norepinephrine; Terlipressin

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Virendra Singh, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 11, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

IN (1)