A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West
 Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the
 treatment of deep grade HE (West Haven Criteria). The study will be conducted retrospectively
 in a multi center of a multispecialty tertiary care hospital in India, in which lactulose
 retention enema is the mainstay of management of cirrhotic patients with grade 3 or 4 HE
 (West Haven criteria). Dosing of lactulose retention enema in this study will be done
 according to the dosing described for rectal administration of lactulose (India): 300ml of
 lactulose mixed with 700ml of potable water to be used as a retention enema; the enema is to
 be retained for 30-60 minutes and repeated every 4-6 hours until the patient is able to take
 oral medication. This treatment regime is also the standard protocol of management of deep
 grade HE (West Haven criteria) in the study centers. The standard treatment protocol of deep
 grade HE (West Haven criteria) of the study centers will also ensure that all known
 contraindications of lactulose will be respected before administration of lactulose retention
 enema to the study patients. The retrospective hospital records of the patient population of
 interest within the past 6 months will be identified, and these records will be used to
 collect data required for analysis.
Data to be collected:

 Data that would be collected for the study as part of retrospective chart review:

 1. Patient demographics: age, gender, weight

 2. Medical history

 3. Etiology of cirrhosis (alcohol abuse, hepatitis, autoimmune, cryptogenic, other)

 4. Diagnosis of cirrhosis

 5. History of previous HE (if yes, the number of episodes in the past)

 6. Grade of HE (as per the West-Haven criteria) at admission, 24 hrs and 48 hours post
 treatment with lactulose

 7. Precipitating factor(s) of HE (Dehydration, GI bleeding, protein overload, constipation,
 infection, others)

 8. Dose and duration of lactulose enema

 9. Treatment given for precipitating factors

 10. Laboratory data on haemoglobin, platelet, bilirubin, albumin, aspartate aminotransferase
 (AST), alanine aminotransferase (ALT), urea, creatinine, sodium, potassium, and blood
 ammonia

 11. Complete reversal of deep-grade HE (< Grade 2 as per West-Haven criteria) (yes/no)

 12. Time to complete reversal of deep-grade HE

 13. Number of days in hospital

 14. Adverse drug reaction experienced by the patient

 15. Complications experienced by the patient

 16. Other pharmacovigilance relevant information (OPRI)
Inclusion Criteria:

 -  Patients aged between 18 and 65 years of either gender.

 -  Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West
 Haven Criteria) HE

 -  Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or
 4 (West Haven Criteria) HE

 Exclusion Criteria:

 -  Patients treated with agents other than lactulose retention enema for grade 3 or 4
 (West Haven Criteria) HE.

 -  Patients who had significant concomitant diseases that could impair or contribute to
 the impairment of consciousness

 -  Patients who had a major neuropsychiatric illness

 -  Patients who had a contraindication to lactulose, including Hypersensitivity to the
 active substance or to any of the ingredients; Galactosaemia; Gastrointestinal
 obstruction, digestive perforation or risk of digestive perforation