Hepatic EncephalopathyPSENCT01283152
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
A study testing Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) and Lactulose in people with Hepatic Encephalopathy and Cirrhosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy
- What is being tested?
- Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) and Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ages 18-80
- Male and female subjects of all races and ethnicities including Spanish speaking subjects
- Cirrhosis of any cause
- Any grade of hepatic encephalopathy (1-4)
- A legally authorized representative has to be able and 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 subjects behalf
Who cannot join
- Acute liver failure
- Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
- Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy)
- Previous use of rifaximin or neomycin in past 7 days
- Prisoners
- Pregnancy
Show all 10Show fewer
- <18 years old
- Serum sodium <125 mEq/L
- Receiving > 1 dose of lactulose prior to enrollment
- Uncontrolled infection with hemodynamic instability requiring vasopressors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System
Dallas, Texas, 75235
About this study
Official title: Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
- Being tested
- Polyethylene glycol 3350-electrolyte solution (GoLYTELY®), Lactulose
- Keywords
- Hepatic Encephalopathy, HE, Cirrhosis, PSE, Portosystemic Encephalopathy, Hepatic coma, AMS, Altered mental status, Complications of cirrhosis, Chronic liver disease
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)Drug
Also called GoLYTELY® or Miralax®
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
LactuloseDrug
If randomized to this arm, subjects will receive 10-30 grams per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) | Active comparator | Not described Receives: Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) |
| Lactulose | Other | Per standard of care Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours
Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA
Measured: Baseline to 24 hours
Change in HE Grade at 24 Hours
Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA
Measured: Baseline to 24 hours
Secondary outcomes (1)
Hospital Duration/Length of Stay
Measured: From time of admission to time of discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Rahimi, MD, MSCR, University of Texas Southwestern Medical Center
- Investigators
- Robert S Rahimi, MD, MSCR, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283152
- Sponsor's protocol ID
- 072010-121
- Acronym
- PSE
- Status last verified
- Dec 2014
- First submitted
- 24 Jan 2011
- Last updated
- 11 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Doran AE, Shah NL. Polyethylene glycol for hepatic encephalopathy: a new solution to purge an old problem? JAMA Intern Med. 2014 Nov;174(11):1734-5. doi: 10.1001/jamainternmed.2014.3501. No abstract available.
PubMed 25244573Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamainternmed.2014.4746.
PubMed 25243839
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.
- ClinicalTrials.gov ID
- NCT01283152
- Acronym / sponsor ID
- PSE / 072010-121
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
- Keywords
- Hepatic Encephalopathy, HE, Cirrhosis, PSE, Portosystemic Encephalopathy, Hepatic coma, AMS, Altered mental status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Posted 11 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) | Active comparator | Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) |
| Lactulose | Other | Drug: LactulosePer standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-80
- Male and female subjects of all races and ethnicities including Spanish speaking subjects
- Cirrhosis of any cause
- Any grade of hepatic encephalopathy (1-4)
- A legally authorized representative has to be able and 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 subjects behalf
Key exclusion criteria (10 listed)
- Acute liver failure
- Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
- Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy)
- Previous use of rifaximin or neomycin in past 7 days
- Prisoners
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 |
|---|---|---|
| Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)Also: GoLYTELY® or Miralax®If randomized to this arm, subjects will receive a 1 time dose of 1 gallon | Drug | Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) |
| LactuloseIf randomized to this arm, subjects will receive 10-30 grams per standard of care | Drug | Lactulose |
Primary outcome
Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours
Time frame: Baseline to 24 hours
Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA
Change in HE Grade at 24 Hours
Time frame: Baseline to 24 hours
Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA
1 secondary outcome
Hospital Duration/Length of Stay
Time frame: From time of admission to time of discharge or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25244573Doran AE, Shah NL. Polyethylene glycol for hepatic encephalopathy: a new solution to purge an old problem? JAMA Intern Med. 2014 Nov;174(11):1734-5. doi: 10.1001/jamainternmed.2014.3501. No abstract available.
- Results publication: PubMed 25243839Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamainternmed.2014.4746.
- PubMed link to abstractLink provided by the sponsor.
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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.
Robert S Rahimi, MD, MSCR principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) and Lactulose in people with Hepatic Encephalopathy and Cirrhosis, run by University of Texas Southwestern Medical Center 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 10 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: finished, as of the sponsor's last update on 11 Dec 2014. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours (time frame: Baseline to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283152, which also lists 2 linked publications.
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 11 Dec 2014.