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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) | Active Comparator |
| |
| Lactulose | Other | Per standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) | Drug | If randomized to this arm, subjects will receive a 1 time dose of 1 gallon |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Duration/Length of Stay | From time of admission to time of discharge or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Rahimi, MD, MSCR | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25244573 | Background | 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. | |
| 25243839 | Result | Rahimi 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. |
| Label | URL |
|---|---|
| PubMed link to abstract | View source |
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A total of 186 patients were screened; 50 eligible patients were randomized to standard-of-care treatment (lactulose) or PEG. The most common reasons for exclusion were that the patient had received more than 1 dose of lactulose in the emergency department prior to consent, that a LAR was not available, or that the patient did not have HE.
This randomized clinical trial was performed at Parkland Memorial Hospital, Dallas, Texas, from January 2011 to June 2012. All patients presenting to the emergency department with known cirrhosis and altered mental status (AMS) were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon |
| FG001 | Lactulose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Lactulose | Drug | If randomized to this arm, subjects will receive 10-30 grams per standard of care |
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Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
| ITT Population |
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| Study Treatment Received |
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| 24-hr HESA Attempted |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon |
| BG001 | Lactulose | Per standard of care Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Cirrhosis cause | Number | participants |
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| White Blood Cell count | Mean | Standard Deviation | cells*10^9/L |
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| Blood Lab Values | Mean | Standard Deviation | mg/dL |
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| International Normalized Ratio (INR) | INR is based on the ratio of the patient's prothrombin time and the normal mean prothrombin time. | Mean | Standard Deviation | unitless (ratio) |
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| Albumin | Mean | Standard Deviation | g/dL |
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| MELD and CTP Scores | Model of End-stage Liver Disease (MELD) score assesses the severity of chronic liver disease. MELD has a range from less than 9 to more than 40 with higher numbers indicating greater severity; Child-Turcotte-Pugh (CTP) score assesses the prognosis of chronic liver disease. CTP has a range from 5 to 15 with higher numbers indicating a worse prognosis. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All participants who completed the study | Posted | Number | participants | Baseline to 24 hours |
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| Secondary | Hospital Duration/Length of Stay | Posted | Mean | Standard Deviation | days | From time of admission to time of discharge or death |
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| Primary | 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 | All participants who completed the study | Posted | Number | participants | Baseline to 24 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon | 3 | 25 | 0 | 25 | ||
| EG001 | Lactulose | Per standard of care Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care | 5 | 25 | 0 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Cardiorespiratory---not related |
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| Death | Gastrointestinal disorders | Hemoperitoneum--Not related |
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| Recurrent HE | Gastrointestinal disorders | Possibly study related |
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| Intubation | Respiratory, thoracic and mediastinal disorders | Probably not related |
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| Hematemesis | Gastrointestinal disorders | Probably not related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert S. Rahimi, M.D., M.S.C.R. Assistant Professor, Department of Medicine | Baylor University Medical Center | 214-820-8500 | Robert.Rahimi@Baylorhealth.edu |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C033608 | Golytely |
| C000595212 | polyethylene glycol 3350 |
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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| Male |
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| Asian |
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| White, Hispanic |
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| White, non-Hispanic |
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| Cryptogenic |
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| Hepatitis C |
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| Hepatitis B |
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| Creatinine |
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| Total Bilirubin |
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| CTP score |
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