Cirrhosis
Conditions
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.
Interventions
DRUGPEG- 17 gm sachet
PEG- 17 gm sachet 3-4 times per day
DRUGLactulose : 20-30gm
Lactulose : 20-30gm
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete reversal of hepatic encephalopathy in both groups. | 3 days | Complete reversal is defined as Grade 0 Encephalopathy |
Secondary
| Measure | Time frame |
|---|---|
| Length of Intensive Care Unit stay in both groups | 28 days |
| Improvement in hepatic encephalopathy by two grades in both groups | 3 days |
| Adverse events in both groups | 3 days |
| Presence of encephalopathy changes in Electroencephalography in both groups | 3 days |
Countries
India
Contacts
Primary ContactDr Abhinav Verma, MD
Outcome results
None listed