NCT02158182

Brief Summary

The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

June 4, 2014

Last Update Submit

May 19, 2018

Conditions

Hepatic Encephalopathy

Keywords

Hepatic EncephalopathyAcute Variceal BleedingCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Development of clinical hepatic encephalopathy

    Determined by West-Haven Criteria

    7 days

Secondary Outcomes (1)

  • Development of minimal hepatic encephalopathy

    7 days

Other Outcomes (1)

  • Development of adverse effects

    7 days

Study Arms (4)

lactulose

EXPERIMENTAL
Drug: Lactulose

L-ornithine L-aspartate

EXPERIMENTAL
Drug: L-ornithine L-aspartate

Rifaximin

EXPERIMENTAL
Drug: Rifaximin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LactuloseDRUG

30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days

lactulose
L-ornithine L-aspartateDRUG

10 grams by intravenous way for 24 hours. Duration of therapy: 7 days

L-ornithine L-aspartate
RifaximinDRUG

2 tablets (400mg) three times daily. Duration of therapy: 7 days

Rifaximin
PlaceboDRUG

Placebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days. Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days. Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria

You may not qualify if:

  • Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Mexico

Mexico City, 06726, Mexico

Location

Related Publications (1)

  • Higuera-de-la-Tijera F, Servin-Caamano AI, Salas-Gordillo F, Perez-Hernandez JL, Abdo-Francis JM, Camacho-Aguilera J, Alla SN, Jimenez-Ponce F. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018 Jul 10;2018:3015891. doi: 10.1155/2018/3015891. eCollection 2018.

    PMID: 30079329DERIVED

MeSH Terms

Conditions

Hepatic EncephalopathyFibrosis

Interventions

LactuloseornithylaspartateRifaximin

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc.

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

ME(1)