TYPE 2 HEPATORENAL SYNDROME (Type2 HRS)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3

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

Treatments: Drug: Terlipressin; Drug: Noradrenaline

Study type: Interventional

Funder types: Other

Identifiers

NCT01637454

PGIMERIndia

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Terlipressin and Type-2 HRS

Active Comparator group

Description:

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.

Treatment:

Drug: Terlipressin

Drug: Noradrenaline

Noradrenaline and Type-2 HRS

Active Comparator group

Description:

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

Treatment:

Drug: Terlipressin

Drug: Noradrenaline