PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Primary Purpose
Hepatic Encephalopathy
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lactulose
Polyethylene Glycol
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- Adult Patients with Overt Hepatic Encephalopathy.
Exclusion Criteria:
- Patients with active GIT bleeding.
- Patients with history of bowel obstruction, perforation.
- Patients with history of allergy to PEG.
- Treatment with rifaximin or neomycin in the previous 7 days.
- Patients with major psychiatric illness.
- Patients receiving benzodiazepines and narcotics.
- Patients with compromised renal.
- Patients receiving medications highly bound to plasma proteins eg. Warfarin.
- Pregnant or lactating women.
- Fulminant hepatic failure.
Sites / Locations
- Tropical medicine dept.-Tanta university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lactulose
Polyeyhylene Glychol
Arm Description
(20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate.
Polyethylene Glycol 3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water)
Outcomes
Primary Outcome Measures
1 or more in HE grade improvement at 24 hours
HE grade improvement at 24 hours
Secondary Outcome Measures
Time to HE resolution
Time to Hepatic encephalopathy resolution
Overall length of stay
Overall length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03100513
Brief Title
PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Official Title
Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2017 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.
Detailed Description
Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactulose
Arm Type
Active Comparator
Arm Description
(20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate.
Arm Title
Polyeyhylene Glychol
Arm Type
Active Comparator
Arm Description
Polyethylene Glycol 3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water)
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Duphlac, lactulose
Intervention Description
(lactulose) (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol
Intervention Description
PEG as single dose of (3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours) dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water).
Primary Outcome Measure Information:
Title
1 or more in HE grade improvement at 24 hours
Description
HE grade improvement at 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to HE resolution
Description
Time to Hepatic encephalopathy resolution
Time Frame
2 weeks
Title
Overall length of stay
Description
Overall length of stay
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Patients with Overt Hepatic Encephalopathy.
Exclusion Criteria:
Patients with active GIT bleeding.
Patients with history of bowel obstruction, perforation.
Patients with history of allergy to PEG.
Treatment with rifaximin or neomycin in the previous 7 days.
Patients with major psychiatric illness.
Patients receiving benzodiazepines and narcotics.
Patients with compromised renal.
Patients receiving medications highly bound to plasma proteins eg. Warfarin.
Pregnant or lactating women.
Fulminant hepatic failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanan Soliman, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amany Abd El-Rahim Abdin, MD
Organizational Affiliation
Tanta university Faculty of Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samah Mosaad Soliman, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hala Hany Shehata, Msc
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Tropical medicine dept.-Tanta university hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
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