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

NCT ID: NCT03448770

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactulsoe

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

Group Type ACTIVE_COMPARATOR

Lactulose : 20-30gm

Intervention Type DRUG

Lactulose : 20-30gm

Polyethlene Glycol

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

Group Type EXPERIMENTAL

PEG- 17 gm sachet

Intervention Type DRUG

PEG- 17 gm sachet 3-4 times per day

Interventions

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PEG- 17 gm sachet

PEG- 17 gm sachet 3-4 times per day

Intervention Type DRUG

Lactulose : 20-30gm

Lactulose : 20-30gm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Documented cirrhosis with any underlying etiology
2. Hepatic encephalopathy of grade II and above
3. 18 to 65 years of age

Exclusion Criteria

1. Acute change in mental status due to a diagnosis other than hepatic encephalopathy
2. Patients who have received lactulose as an anticoma measure before enrollment
3. Patient who have developed encephalopathy post bleed
4. Patients with gut paralysis
5. Patients with tense ascites
6. Patients with altered sensorium due to organic brain disease.
7. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
8. Hemodynamic instability obviating vasopressors for resuscitation
9. 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
10. Refusal of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr Abhinav Verma, MD

Role: CONTACT

Phone: 01146300000

Email: [email protected]

Facility Contacts

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Dr Abhinav Verma, MD

Role: primary

Other Identifiers

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ILBS-cirrhosis-14

Identifier Type: -

Identifier Source: org_study_id