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 Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377947
• Other study ID #: EPIDJ001
• Secondary ID: REF/2014/11/0079
• Status: Completed
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2020
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Locations

Country	Name	City	State
India	Medanta Hospital	Gurgaon
India	Research facility ORG-000333	Gurgaon
India	Sir Ganga Ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).	Safety of Lactulose retention enema (number of adverse drug reactions & complications). Complications pertinent to lactulose retention enema are in reference to potential adverse effects associated with the use of rectal device associated with the application of the lactulose retention enema kit.	Chart Review of Events over 48 Hour Period
Other	Reduction in Blood Ammonia Level	Change from baseline was calculated at the end of treatment by using following formula wherever applicable: Change from baseline = Blood ammonia level at the end of treatment - Blood ammonia level at baseline	reported at 48 hrs
Other	Duration of Hospital Stay		upto 30 days of hospital admission
Primary	Complete Reversal	Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema	24 hrs
Primary	Complete Reversal	Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema	48 hrs
Secondary	Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours	Grade shift at 24 and 48 hours - from baseline to 24 and 48 hours post administration of lactulose retention enema.; Complete reversal of deep grade HE is defined as subjects having HE grade=	HE Grade shift at 24 hrs and HE Grade shift at 48 hrs
Secondary	Time to Complete Reversal	Time to complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) HE after administration of lactulose retention enema	up to 48 hrs
Secondary	Mortality	Mortality in patients treated with lactulose retention enema	within 48 hrs