TYPE 2 HEPATORENAL SYNDROME

Phase 3

Completed

• Conditions: Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS
• Interventions: Drug: Noradrenaline; Drug: Terlipressin

• Registration Number: NCT01637454
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-06-28
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terlipressin and Type-2 HRS	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.
Terlipressin and Type-2 HRS	Noradrenaline	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	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
Noradrenaline and Type-2 HRS	Terlipressin	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

Primary Outcome Measures

Name	Time	Method
The primary end point of the study was serum creatinine less than 1.5 mg	15 days

Secondary Outcome Measures

Name	Time	Method
Secondary end points include death of patients	15 days

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research Chandigarh; 🇮🇳 Chandigarh, India