N/A
N=50
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]
Hepatic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT02377947 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Complete Reversal — 80 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Reversal |
90 | — |
| PRIMARY Complete Reversal |
90 | — |
| SECONDARY Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours |
86.67; 20.0; 95.56; 40.0 | — |
| SECONDARY Time to Complete Reversal |
25.39 | — |
| SECONDARY Mortality |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02377947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.