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]

NCT ID: NCT02377947

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

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)

Conditions

Hepatic Encephalopathy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Patients with cirrhosis (grade 3 & 4 per west haven cr.)

Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dyotona Roy-Sengupta

Role: STUDY_CHAIR

Abbott

Locations

Medanta Hospital

Gurgaon, , India

Research facility ORG-000333

Gurgaon, , India

Sir Ganga Ram Hospital

New Delhi, , India

Countries

India

Other Identifiers

REF/2014/11/007981

Identifier Type: REGISTRY

Identifier Source: secondary_id

EPIDJ001

Identifier Type: -

Identifier Source: org_study_id