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]

NCT02377947 | Completed Results

• 2 other identifiers: EPIDJ001REF/2014/11/007981
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Encephalopathy

Keywords

Lactulose Retention Enema; Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria; The Retro Study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours

  HE Grade shift at 24 hrs and HE Grade shift at 48 hrs

• Time to Complete Reversal

  up to 48 hrs

• Mortality

  within 48 hrs

Other Outcomes (3)

• Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).

  Chart Review of Events over 48 Hour Period

• Reduction in Blood Ammonia Level

  reported at 48 hrs

• Duration of Hospital Stay

  upto 30 days of hospital admission

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (3)

Medanta Hospital

Gūrgaon, 122001, India

Location

Research facility ORG-000333

Gūrgaon, 122001, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Shubhangi Desai
• Organization: Abbott

shubhangi.desai@abbott.com

+91 22 7175 7408

Study Officials

• Dyotona Roy-Sengupta

  Abbott

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 4, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Locations

IN (3)