An interventional study of Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) and Lactulose in Hepatic Encephalopathy, Cirrhosis and Portosystemic Encephalopathy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-11.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Per standard of care
Drug: Lactulose
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
Also known as: GoLYTELY® or Miralax®
If randomized to this arm, subjects will receive 10-30 grams per standard of care
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
Time frame: 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
Time frame: Baseline to 24 hours
Hospital Duration/Length of Stay
Time frame: From time of admission to time of discharge or death
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.
| Milestone | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose |
|---|---|---|
| Started | 25 | 25 |
| Itt population | 25 | 25 |
| Study treatment received | 25 | 25 |
| 24-hr hesa attempted | 25 | 25 |
| Completed | 23 | 25 |
| Not completed | 2 | 0 |
| Withdrew: Discharged prior to 24 hr assessment | 1 | 0 |
| Withdrew: Refused hesa | 1 | 0 |
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
| participants | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose |
|---|---|---|
| Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours | 21 | 13 |
| days | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose |
|---|---|---|
| Hospital Duration/Length of Stay | 4 ± 3 | 8 ± 12 |
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
| participants | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose |
|---|---|---|
| improvement of 1 HESA grade | 10 | 9 |
| improvement of 2 HESA grades | 9 | 3 |
| improvement of 3 HESA grades | 1 | 1 |
| No HESA improvement | 2 | 12 |
| HESA grade 0 at 24 hours | 10 | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | — | 3/25 (12%) | 0/25 (0%) |
| Lactulose | — | 5/25 (20%) | 0/25 (0%) |
| Event | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose |
|---|---|---|
| DeathCardiac disorders | 0/25 | 2/25 |
| Recurrent HEGastrointestinal disorders | 2/25 | 1/25 |
| DeathGastrointestinal disorders | 1/25 | 0/25 |
| IntubationRespiratory, thoracic and mediastinal disorders | 0/25 | 1/25 |
| HematemesisGastrointestinal disorders | 0/25 | 1/25 |
| Age, Continuous(years) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| Mean | 56 ± 7 | 56 ± 11 | 56 ± 9 |
| Sex: Female, Male(Participants) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 16 | 15 | 31 |
| Race/Ethnicity, Customized(participants) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| African American | 2 | 2 | 4 |
| Asian | 1 | 0 | 1 |
| White, Hispanic | 20 | 15 | 35 |
| White, non-Hispanic | 2 | 8 | 10 |
| Region of Enrollment(participants) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
| Cirrhosis cause(participants) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| Alcoholic Liver Disease | 10 | 9 | 19 |
| Cryptogenic | 6 | 6 | 12 |
| Hepatitis C | 8 | 9 | 17 |
| Hepatitis B | 1 | 1 | 2 |
| White Blood Cell count(cells*10^9/L) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| Mean | 6.3 ± 2.6 | 6.2 ± 2.6 | 6.2 ± 2.6 |
| Blood Lab Values(mg/dL) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| Blood Urea Nitrogen | 30 ± 17 | 21 ± 11 | 26 ± 15 |
| Creatinine | 1.7 ± 1.29 | 1.12 ± 0.52 | 1.41 ± 1.02 |
| Total Bilirubin | 3.6 ± 3 | 2.9 ± 1.4 | 3.3 ± 2.3 |
| International Normalized Ratio (INR)(unitless (ratio)) | Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) | Lactulose | Total |
|---|---|---|---|
| Mean | 1.5 ± 0.4 | 1.4 ± 0.3 | 1.5 ± 0.4 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center