Status:
UNKNOWN
To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Documented cirrhosis with any underlying etiology
- Hepatic encephalopathy of grade II and above
- 18 to 65 years of age
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03448770
Start Date
August 1 2017
End Date
July 31 2018
Last Update
February 28 2018
Active Locations (1)
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1
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070