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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03448770
Other study ID # ILBS-cirrhosis-14
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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