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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
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult Patients with Overt Hepatic Encephalopathy.

Exclusion Criteria:

  1. Patients with active GIT bleeding.
  2. Patients with history of bowel obstruction, perforation.
  3. Patients with history of allergy to PEG.
  4. Treatment with rifaximin or neomycin in the previous 7 days.
  5. Patients with major psychiatric illness.
  6. Patients receiving benzodiazepines and narcotics.
  7. Patients with compromised renal.
  8. Patients receiving medications highly bound to plasma proteins eg. Warfarin.
  9. Pregnant or lactating women.
  10. 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

First Posted
March 24, 2017
Last Updated
April 25, 2017
Sponsor
Sherief Abd-Elsalam
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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

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PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

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