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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448770
• Other study ID #: ILBS-cirrhosis-14
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2018
• Last updated: February 27, 2018
• Start date: August 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: February 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Abhinav Verma, MD
• Phone: 01146300000
• Email: abhinav.3183[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy

Intervention

Drug:
• PEG- 17 gm sachet
PEG- 17 gm sachet 3-4 times per day
• Lactulose : 20-30gm
Lactulose : 20-30gm

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete reversal of hepatic encephalopathy in both groups.	Complete reversal is defined as Grade 0 Encephalopathy	3 days
Secondary	Improvement in hepatic encephalopathy by two grades in both groups		3 days
Secondary	Length of Intensive Care Unit stay in both groups		28 days
Secondary	Adverse events in both groups		3 days
Secondary	Presence of encephalopathy changes in Electroencephalography in both groups		3 days