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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cirrhosis
• Intervention / Treatment: Drug: Lactulose : 20-30gm; Drug: PEG- 17 gm sachet

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver and Biliary Sciences
      • Contact: Dr Abhinav Verma, MD; Phone Number: 01146300000; Email: abhinav.3183@gmail.com
      • Principal Investigator: Dr Abhinav Verma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lactulsoe; Lactulose : 20-30gm 2-3 doses per day	Drug: Lactulose : 20-30gm; Lactulose : 20-30gm
EXPERIMENTAL: Polyethlene Glycol; PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day	Drug: PEG- 17 gm sachet; PEG- 17 gm sachet 3-4 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete reversal of hepatic encephalopathy in both groups.	Complete reversal is defined as Grade 0 Encephalopathy	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in hepatic encephalopathy by two grades in both groups	3 days
Length of Intensive Care Unit stay in both groups	28 days
Adverse events in both groups	3 days
Presence of encephalopathy changes in Electroencephalography in both groups	3 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): July 31, 2018
• Study Completion (ANTICIPATED): July 31, 2018

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: ILBS-cirrhosis-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No