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

Not Applicable

• Conditions: Cirrhosis
• Interventions: Drug: PEG- 17 gm sachet

• Registration Number: NCT03448770
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study First Posted: 2018-02-28
• Last Update Posted: 2018-02-28
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Complete reversal of hepatic encephalopathy in both groups.	3 days	Complete reversal is defined as Grade 0 Encephalopathy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India