drugset / Trial / NCT02573727

To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure

NCT02573727

RandomizedParallel-groupOpen-labelTreatment

Summary

Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed. If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.

Timeline

Start
2015-10
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Noradrenaline Unknown 0.5 mg Intravenous
Comparator Terlipressin Peptide 2 mg Intravenous
Background Albumin Protein / enzyme biologic 1 g/kg

Indications