Trial Outcomes & Findings for Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy. (NCT NCT01283152)
NCT ID: NCT01283152
Last Updated: 2014-12-11
Results Overview
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
COMPLETED
NA
50 participants
Baseline to 24 hours
2014-12-11
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
Lactulose
Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
ITT Population
|
25
|
25
|
|
Overall Study
Study Treatment Received
|
25
|
25
|
|
Overall Study
24-hr HESA Attempted
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
Lactulose
Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
|
|---|---|---|
|
Overall Study
Discharged prior to 24 hr assessment
|
1
|
0
|
|
Overall Study
Refused HESA
|
1
|
0
|
Baseline Characteristics
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
Baseline characteristics by cohort
| Measure |
Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)
n=25 Participants
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
|
Lactulose
n=25 Participants
Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 7 • n=99 Participants
|
56 years
STANDARD_DEVIATION 11 • n=107 Participants
|
56 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic
|
20 participants
n=99 Participants
|
15 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
2 participants
n=99 Participants
|
8 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Cirrhosis cause
Alcoholic Liver Disease
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Cirrhosis cause
Cryptogenic
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Cirrhosis cause
Hepatitis C
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Cirrhosis cause
Hepatitis B
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
White Blood Cell count
|
6.3 cells*10^9/L
STANDARD_DEVIATION 2.6 • n=99 Participants
|
6.2 cells*10^9/L
STANDARD_DEVIATION 2.6 • n=107 Participants
|
6.2 cells*10^9/L
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Blood Lab Values
Blood Urea Nitrogen
|
30 mg/dL
STANDARD_DEVIATION 17 • n=99 Participants
|
21 mg/dL
STANDARD_DEVIATION 11 • n=107 Participants
|
26 mg/dL
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Blood Lab Values
Creatinine
|
1.7 mg/dL
STANDARD_DEVIATION 1.29 • n=99 Participants
|
1.12 mg/dL
STANDARD_DEVIATION 0.52 • n=107 Participants
|
1.41 mg/dL
STANDARD_DEVIATION 1.02 • n=206 Participants
|
|
Blood Lab Values
Total Bilirubin
|
3.6 mg/dL
STANDARD_DEVIATION 3 • n=99 Participants
|
2.9 mg/dL
STANDARD_DEVIATION 1.4 • n=107 Participants
|
3.3 mg/dL
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
International Normalized Ratio (INR)
|
1.5 unitless (ratio)
STANDARD_DEVIATION 0.4 • n=99 Participants
|
1.4 unitless (ratio)
STANDARD_DEVIATION 0.3 • n=107 Participants
|
1.5 unitless (ratio)
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Albumin
|
2.7 g/dL
STANDARD_DEVIATION 0.6 • n=99 Participants
|
2.8 g/dL
STANDARD_DEVIATION 0.5 • n=107 Participants
|
2.7 g/dL
STANDARD_DEVIATION 0.6 • n=206 Participants
|
|
MELD and CTP Scores
MELD score
|
17 units on a scale
STANDARD_DEVIATION 6 • n=99 Participants
|
17 units on a scale
STANDARD_DEVIATION 5 • n=107 Participants
|
17 units on a scale
STANDARD_DEVIATION 5 • n=206 Participants
|
|
MELD and CTP Scores
CTP score
|
10 units on a scale
STANDARD_DEVIATION 2 • n=99 Participants
|
10 units on a scale
STANDARD_DEVIATION 1 • n=107 Participants
|
10 units on a scale
STANDARD_DEVIATION 2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursPopulation: All participants who completed the study
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
Outcome measures
| Measure |
Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)
n=23 Participants
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
|
Lactulose
n=25 Participants
Per standard of care
Lactulose: 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
|
21 participants
|
13 participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursPopulation: All participants who completed the study
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
Outcome measures
| Measure |
Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)
n=23 Participants
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
|
Lactulose
n=25 Participants
Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
|
|---|---|---|
|
Change in HE Grade at 24 Hours
improvement of 1 HESA grade
|
10 participants
|
9 participants
|
|
Change in HE Grade at 24 Hours
improvement of 2 HESA grades
|
9 participants
|
3 participants
|
|
Change in HE Grade at 24 Hours
improvement of 3 HESA grades
|
1 participants
|
1 participants
|
|
Change in HE Grade at 24 Hours
No HESA improvement
|
2 participants
|
12 participants
|
|
Change in HE Grade at 24 Hours
HESA grade 0 at 24 hours
|
10 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From time of admission to time of discharge or deathOutcome measures
| Measure |
Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)
n=25 Participants
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
|
Lactulose
n=25 Participants
Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
|
|---|---|---|
|
Hospital Duration/Length of Stay
|
4 days
Standard Deviation 3
|
8 days
Standard Deviation 12
|
Adverse Events
Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)
Lactulose
Serious adverse events
| Measure |
Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)
n=25 participants at risk
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
|
Lactulose
n=25 participants at risk
Per standard of care
Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
|
|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/25
|
8.0%
2/25
|
|
Gastrointestinal disorders
Death
|
4.0%
1/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Recurrent HE
|
8.0%
2/25
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/25
|
4.0%
1/25
|
Other adverse events
Adverse event data not reported
Additional Information
Robert S. Rahimi, M.D., M.S.C.R. Assistant Professor, Department of Medicine
Baylor University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place