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]
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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)
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Retrospective study - data charts of the cirrhotic patients having grade III and IV and who
        were administered lactulose enema will be reviewed.
      
Keywords: Lactulose Retention Enema; Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria; The Retro Study