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

NCT ID: NCT02573727

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Acute on Chronic Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nor adrenaline + albumin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Terlipressin + albumin

Intervention Type DRUG

Interventions

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Nor adrenaline + albumin

Intervention Type DRUG

Terlipressin + albumin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Vinod Arora, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-ACLF-004

Identifier Type: -

Identifier Source: org_study_id