Clinical trial NCT02377947: 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]
Official title: 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]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Encephalopathy
Keywords: Lactulose Retention Enema
Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria
The Retro Study
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Complete Reversal
timeFrame: 24 hrs
measure: Complete Reversal
timeFrame: 48 hrs
Secondary outcomes:
measure: Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours
timeFrame: HE Grade shift at 24 hrs and HE Grade shift at 48 hrs
measure: Time to Complete Reversal
timeFrame: up to 48 hrs
measure: Mortality
timeFrame: within 48 hrs
Other outcomes:
measure: Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).
timeFrame: Chart Review of Events over 48 Hour Period
measure: Reduction in Blood Ammonia Level
timeFrame: reported at 48 hrs
measure: Duration of Hospital Stay
timeFrame: upto 30 days of hospital admission
Locations:
city: Gurgaon
country: India
facility: Medanta Hospital
city: Gurgaon
country: India
facility: Research facility ORG-000333
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
Study officials:
affiliation: Abbott
name: Dyotona Roy-Sengupta
role: STUDY_CHAIR
References: