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Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Primary Purpose

Hepatic Encephalopathy

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Lactulose
L-ornithine L-aspartate
Rifaximin
Placebo
Sponsored by
Hospital General de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, Acute Variceal Bleeding, Cirrhosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital General de Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

lactulose

L-ornithine L-aspartate

Rifaximin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Development of clinical hepatic encephalopathy
Determined by West-Haven Criteria

Secondary Outcome Measures

Development of minimal hepatic encephalopathy
Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)

Full Information

First Posted
June 4, 2014
Last Updated
May 19, 2018
Sponsor
Hospital General de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02158182
Brief Title
Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
Official Title
Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Hepatic Encephalopathy, Acute Variceal Bleeding, Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lactulose
Arm Type
Experimental
Arm Title
L-ornithine L-aspartate
Arm Type
Experimental
Arm Title
Rifaximin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
L-ornithine L-aspartate
Intervention Description
10 grams by intravenous way for 24 hours. Duration of therapy: 7 days
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
2 tablets (400mg) three times daily. Duration of therapy: 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Development of clinical hepatic encephalopathy
Description
Determined by West-Haven Criteria
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Development of minimal hepatic encephalopathy
Description
Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Development of adverse effects
Description
Side or adverse effect will be defined as an undesirable secondary effect which occurs in addition to the desired therapeutic effect of a drug or medication. Non serious side effect will be defined as an undesirable secondary effect that does not represents a risk for patient´s life or function. Particularly we will addressed: Diarrhea, bloating, nausea, vomiting, elevation of serum creatinine, flatulence, abdominal pain, constipation, headache, dizziness Serious side effect will be defined as an undesirable secondary effect that represents a risk for patient´s life or function. Particularly we will addressed: allergic reactions.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria Exclusion Criteria: 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.
Facility Information:
Facility Name
Hospital General de Mexico
City
Mexico City
ZIP/Postal Code
06726
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
30079329
Citation
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.
Results Reference
derived

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Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

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