NCT02573727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

October 5, 2015

Last Update Submit

November 14, 2017

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Response to treatment in each intervention group

    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.

    14 days

Secondary Outcomes (2)

  • Survival

    28 days

  • Drug related Side effects/complications

    28 days

Study Arms (2)

Nor Adrenaline + Albumin

EXPERIMENTAL

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.

Drug: Nor adrenaline + albumin

Terlipressin + Albumin

ACTIVE COMPARATOR

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.

Drug: Terlipressin + albumin

Interventions

Nor adrenaline + albuminDRUG
Nor Adrenaline + Albumin
Terlipressin + albuminDRUG
Terlipressin + Albumin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

NorepinephrineAlbuminsTerlipressin

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsProteinsAmino Acids, Peptides, and ProteinsLypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesOligopeptidesNerve Tissue Proteins

Study Officials

  • Dr Vinod Arora, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 12, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 17, 2017

Record last verified: 2016-07

Locations

IN(1)