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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02573727

Enrollment

120

Registered

2015-10-12

Start date

2015-10-31

Completion date

2017-01-31

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute on Chronic Liver Failure

Brief 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.

Interventions

DRUGNor adrenaline + albumin

DRUGTerlipressin + albumin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients with acute on chronic liver failure presenting with hepatorenal syndrome 2. Patients consented for the study protocol by signing the informed consent.

Exclusion criteria

1. Age less than 18 years 2. Decompensated cirrhotics 3. Evidence of chronic kidney disease 4. Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation). 5. Post liver transplantation patients. 6. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease. 7. Patients with obstructive uropathy. 8. Patient who withdrew or non complaint to the study protocol.

Design outcomes

Primary

Measure	Time frame	Description
Response to treatment in each intervention group	14 days	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.

Secondary

Measure	Time frame
Survival	28 days
Drug related Side effects/complications	28 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026