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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Cirrhosis

Treatments: Drug: PEG- 17 gm sachet; Drug: Lactulose : 20-30gm

Study type: Interventional

Funder types: Other

Identifiers

NCT03448770

ILBS-cirrhosis-14

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Lactulsoe

Active Comparator group

Description:

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

Treatment:

Drug: Lactulose : 20-30gm

Polyethlene Glycol

Experimental group

Description:

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

Treatment:

Drug: PEG- 17 gm sachet