Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS
Conditions
Keywords
noradrenaline terlipressin type 2 HRS
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
Interventions
DRUGNoradrenaline
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
DRUGTerlipressin
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
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the study was serum creatinine less than 1.5 mg | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points include death of patients | 15 days |
Countries
India
Outcome results
None listed