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

NCT03448770 | Unknown

• 1 other identifier: ILBS-cirrhosis-14
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Complete reversal of hepatic encephalopathy in both groups.

  Complete reversal is defined as Grade 0 Encephalopathy

  3 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Lactulsoe

ACTIVE COMPARATOR

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

Drug: Lactulose : 20-30gm

Polyethlene Glycol

EXPERIMENTAL

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

Drug: PEG- 17 gm sachet

Interventions

PEG- 17 gm sachet DRUG

PEG- 17 gm sachet 3-4 times per day

Polyethlene Glycol

Lactulose : 20-30gm DRUG

Lactulose : 20-30gm

Lactulsoe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented cirrhosis with any underlying etiology
• Hepatic encephalopathy of grade II and above
• to 65 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Abhinav Verma, MD

CONTACT

01146300000; abhinav.3183@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 28, 2018
• Study Start: August 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

IN (1)