Hepatic EncephalopathyHELPNCT01923376
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
A study testing Lactulose and Polyethylene Glycol 3350 in people with Hepatic Encephalopathy and HE, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy, HE, Cirrhosis
- What is being tested?
- Lactulose and Polyethylene Glycol 3350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80
- Male and female of all races and ethnicities
- Cirrhosis of any cause
- Any grade of hepatic encephalopathy (1-4)
- Representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf
Who cannot join
- Acute liver failure
- Prisoners
- Structural brain lesions (as indicated by CT and confirmed by neurological exam)
- Other causes of altered mental status
- Previous use of rifaximin or neomycin within last 7 days
- Pregnancy
Show all 9Show fewer
- Serum Na <125 MEq/liter
- Receiving more than 1 dose (30 cc) of lactulose prior to enrollment
- Uncontrolled infection with hemodynamic instability requiring vasopressors.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.
Read the detailed description
Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.
- Conditions
- Hepatic Encephalopathy, HE, Cirrhosis, Altered Mental Status, AMS
- Being tested
- Lactulose, Polyethylene Glycol 3350
- Keywords
- hepatic encephalopathy, hepatic coma, HE, PSE, lactulose, golytely, cirrhosis, Hepatic Insufficiency, Liver Cirrhosis, Fibrosis, Brain Damage, Chronic, Delirium, Encephalitis, Neurotoxicity Syndromes, Liver Failure, Liver Diseases, Digestive System Diseases, Brain Diseases, Metabolic, Brain Diseases, Central Nervous System Diseases
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis, Hepatic Insufficiency, Liver Cirrhosis, Brain Damage, Chronic, Delirium, Encephalitis, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
Also called Enulose, Duphalac, generlac, kristalose
If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care
Polyethylene Glycol 3350Drug
Also called Miralax, Golytely
If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment
| Study group | Role | What they receive |
|---|---|---|
| Lactulose | Other | per standard of care Receives: Drug: Lactulose |
| polyethylene glycol 3350 (Golytely) | Active comparator | Not described Receives: Drug: Polyethylene Glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of cognition
Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare
Measured: 24 hours from the time of enrollment
Secondary outcomes (1)
Duration of hospital stay
To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay
Measured: From time of admission to time of discharge an approximate length of seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Not enough staff to collect data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Smruti R Mohanty, MD, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Smruti R Mohanty, MD, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923376
- Sponsor's protocol ID
- 401550
- Acronym
- HELP
- Status last verified
- May 2015
- First submitted
- 25 Jul 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
- ClinicalTrials.gov ID
- NCT01923376
- Acronym / sponsor ID
- HELP / 401550
- Conditions
- Hepatic Encephalopathy, HE, Cirrhosis, Altered Mental Status, AMS
- Keywords
- hepatic encephalopathy, hepatic coma, HE, PSE, lactulose, golytely, cirrhosis, Hepatic Insufficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough staff to collect data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.
Detailed description
Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose | Other | Drug: Lactuloseper standard of care |
| polyethylene glycol 3350 (Golytely) | Active comparator | Drug: Polyethylene Glycol 3350 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 80
- Male and female of all races and ethnicities
- Cirrhosis of any cause
- Any grade of hepatic encephalopathy (1-4)
- Representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf
Key exclusion criteria (9 listed)
- Acute liver failure
- Prisoners
- Structural brain lesions (as indicated by CT and confirmed by neurological exam)
- Other causes of altered mental status
- Previous use of rifaximin or neomycin within last 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactuloseAlso: Enulose, Duphalac, generlac, kristaloseIf randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care | Drug | Lactulose |
| Polyethylene Glycol 3350Also: Miralax, GolytelyIf subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment | Drug | polyethylene glycol 3350 (Golytely) |
Primary outcome
Improvement of cognition
Time frame: 24 hours from the time of enrollment
Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare
1 secondary outcome
Duration of hospital stay
Time frame: From time of admission to time of discharge an approximate length of seven days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Smruti R Mohanty, MD principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose and Polyethylene Glycol 3350 in people with Hepatic Encephalopathy and HE, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of cognition (time frame: 24 hours from the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.