TYPE 2 HEPATORENAL SYNDROME

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

— Type2 HRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637454
• Other study ID #: PGIMERIndia
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2012
• Last updated: July 10, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl

2. Absence of shock, fluid losses and treatment with nephrotoxic drug

3. No improvement in renal function following diuretic withdrawal and plasma volume expansion

4. No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour

Exclusion Criteria:

1. Patients with history of coronary artery disease

2. Cardiomyopathy

3. Ventricular arrhythmia

4. Obstructive arterial disease of limbs -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Noradrenaline
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
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

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research Chandigarh	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (1)

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 Hepat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point of the study was serum creatinine less than 1.5 mg		15 days	No
Secondary	Secondary end points include death of patients		15 days	Yes