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

Not Applicable

Completed

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Nor adrenaline + albumin; Drug: Terlipressin + albumin

• Registration Number: NCT02573727
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Status Verified: 2016-07
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nor Adrenaline + Albumin	Nor adrenaline + albumin	Intravenous continous infusion of terlipressin at the dose of 2 mg every 24 hours with the maximum daily cumulative dose of 12 mg/day. In case of no response the dose of the terlipressin will be progressively increased to the maximum infusion dose of 12 mg/24 hour. Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.
Terlipressin + Albumin	Terlipressin + albumin	Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours designed to achieve an increase in MAP of at least 10 mmHg or an increase in 4-h urine output of more than 200 ml. When one of these goals was not achieved, the noradrenaline dose was increased every 4 h in steps of 0.5 mg/h, up to the maximum dose of 3 mg/h. Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Drug related Side effects/complications	28 days
Survival	28 days

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India