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To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

Primary Purpose

Cirrhosis

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

PEG- 17 gm sachet

Lactulose : 20-30gm

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Documented cirrhosis with any underlying etiology
Hepatic encephalopathy of grade II and above
18 to 65 years of age

Exclusion Criteria:

Acute change in mental status due to a diagnosis other than hepatic encephalopathy
Patients who have received lactulose as an anticoma measure before enrollment
Patient who have developed encephalopathy post bleed
Patients with gut paralysis
Patients with tense ascites
Patients with altered sensorium due to organic brain disease.
Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
Hemodynamic instability obviating vasopressors for resuscitation
Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease
Refusal of consent

Sites / Locations

Institute of liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lactulsoe

Polyethlene Glycol

Arm Description

Lactulose : 20-30gm 2-3 doses per day

PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day

Outcomes

Primary Outcome Measures

Complete reversal of hepatic encephalopathy in both groups.

Complete reversal is defined as Grade 0 Encephalopathy

Secondary Outcome Measures

Improvement in hepatic encephalopathy by two grades in both groups

Length of Intensive Care Unit stay in both groups

Adverse events in both groups

Presence of encephalopathy changes in Electroencephalography in both groups

Full Information

NCT ID

NCT03448770

First Posted

February 19, 2018

Last Updated

February 27, 2018

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT03448770

Brief Title

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

Official Title

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

July 31, 2018 (Anticipated)

Study Completion Date

July 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactulsoe

Arm Type

Active Comparator

Arm Description

Lactulose : 20-30gm 2-3 doses per day

Arm Title

Polyethlene Glycol

Arm Type

Experimental

Arm Description

PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day

Intervention Type

Drug

Intervention Name(s)

PEG- 17 gm sachet

Intervention Description

PEG- 17 gm sachet 3-4 times per day

Intervention Type

Drug

Intervention Name(s)

Lactulose : 20-30gm

Intervention Description

Lactulose : 20-30gm

Primary Outcome Measure Information:

Title

Complete reversal of hepatic encephalopathy in both groups.

Description

Complete reversal is defined as Grade 0 Encephalopathy

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Improvement in hepatic encephalopathy by two grades in both groups

Time Frame

3 days

Title

Length of Intensive Care Unit stay in both groups

Time Frame

28 days

Title

Adverse events in both groups

Time Frame

3 days

Title

Presence of encephalopathy changes in Electroencephalography in both groups

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented cirrhosis with any underlying etiology Hepatic encephalopathy of grade II and above 18 to 65 years of age Exclusion Criteria: Acute change in mental status due to a diagnosis other than hepatic encephalopathy Patients who have received lactulose as an anticoma measure before enrollment Patient who have developed encephalopathy post bleed Patients with gut paralysis Patients with tense ascites Patients with altered sensorium due to organic brain disease. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy Hemodynamic instability obviating vasopressors for resuscitation Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease Refusal of consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Abhinav Verma, MD

Phone

01146300000

abhinav.3183@gmail.com

Facility Information:

Facility Name

Institute of liver and Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Abhinav Verma, MD

Phone

01146300000

abhinav.3183@gmail.com

First Name & Middle Initial & Last Name & Degree

Dr Abhinav Verma, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

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