Trial Outcomes & Findings for Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy. (NCT 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

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline to 24 hours

Results posted on

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

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

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

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=5 Participants	56 years STANDARD_DEVIATION 11 • n=7 Participants	56 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White, Hispanic	20 participants n=5 Participants	15 participants n=7 Participants	35 participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	2 participants n=5 Participants	8 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Cirrhosis cause Alcoholic Liver Disease	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Cirrhosis cause Cryptogenic	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Cirrhosis cause Hepatitis C	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Cirrhosis cause Hepatitis B	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
White Blood Cell count	6.3 cells*10^9/L STANDARD_DEVIATION 2.6 • n=5 Participants	6.2 cells*10^9/L STANDARD_DEVIATION 2.6 • n=7 Participants	6.2 cells*10^9/L STANDARD_DEVIATION 2.6 • n=5 Participants
Blood Lab Values Blood Urea Nitrogen	30 mg/dL STANDARD_DEVIATION 17 • n=5 Participants	21 mg/dL STANDARD_DEVIATION 11 • n=7 Participants	26 mg/dL STANDARD_DEVIATION 15 • n=5 Participants
Blood Lab Values Creatinine	1.7 mg/dL STANDARD_DEVIATION 1.29 • n=5 Participants	1.12 mg/dL STANDARD_DEVIATION 0.52 • n=7 Participants	1.41 mg/dL STANDARD_DEVIATION 1.02 • n=5 Participants
Blood Lab Values Total Bilirubin	3.6 mg/dL STANDARD_DEVIATION 3 • n=5 Participants	2.9 mg/dL STANDARD_DEVIATION 1.4 • n=7 Participants	3.3 mg/dL STANDARD_DEVIATION 2.3 • n=5 Participants
International Normalized Ratio (INR)	1.5 unitless (ratio) STANDARD_DEVIATION 0.4 • n=5 Participants	1.4 unitless (ratio) STANDARD_DEVIATION 0.3 • n=7 Participants	1.5 unitless (ratio) STANDARD_DEVIATION 0.4 • n=5 Participants
Albumin	2.7 g/dL STANDARD_DEVIATION 0.6 • n=5 Participants	2.8 g/dL STANDARD_DEVIATION 0.5 • n=7 Participants	2.7 g/dL STANDARD_DEVIATION 0.6 • n=5 Participants
MELD and CTP Scores MELD score	17 units on a scale STANDARD_DEVIATION 6 • n=5 Participants	17 units on a scale STANDARD_DEVIATION 5 • n=7 Participants	17 units on a scale STANDARD_DEVIATION 5 • n=5 Participants
MELD and CTP Scores CTP score	10 units on a scale STANDARD_DEVIATION 2 • n=5 Participants	10 units on a scale STANDARD_DEVIATION 1 • n=7 Participants	10 units on a scale STANDARD_DEVIATION 2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 hours

Population: All participants who completed the study

Outcome measures

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 hours

Population: 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

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 No HESA improvement	2 participants	12 participants
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 HESA grade 0 at 24 hours	10 participants	2 participants

SECONDARY outcome

Timeframe: From time of admission to time of discharge or death

Outcome measures

Outcome 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®)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Lactulose

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

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

Phone: 214-820-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place