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

Study Overview
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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.

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

Conditions
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Cirrhosis

Intervention / Treatment
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* Drug: PEG- 17 gm sachet
* Drug: Lactulose : 20-30gm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactulsoe<br>Lactulose : 20-30gm 2-3 doses per day | Drug: Lactulose : 20-30gm<br>* Lactulose : 20-30gm<br>|
| Experimental: Polyethlene Glycol<br>PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day | Drug: PEG- 17 gm sachet<br>* PEG- 17 gm sachet 3-4 times per day<br>|

What is the study measuring?
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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 | Measure Description | 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 |