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NCT Number: 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]

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medanta Hospital, Gurgaon, India

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About this study

Data to be collected:

Data that would be collected for the study as part of retrospective chart review:

  • Patient demographics: age, gender, weight
  • Medical history
  • Etiology of cirrhosis (alcohol abuse, hepatitis, autoimmune, cryptogenic, other)
  • Diagnosis of cirrhosis
  • History of previous HE (if yes, the number of episodes in the past)
  • Grade of HE (as per the West-Haven criteria) at admission, 24 hrs and 48 hours post treatment with lactulose
  • Precipitating factor(s) of HE (Dehydration, GI bleeding, protein overload, constipation, infection, others)
  • Dose and duration of lactulose enema
  • Treatment given for precipitating factors
  • Laboratory data on haemoglobin, platelet, bilirubin, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine, sodium, potassium, and blood ammonia
  • Complete reversal of deep-grade HE (< Grade 2 as per West-Haven criteria) (yes/no)
  • Time to complete reversal of deep-grade HE
  • Number of days in hospital
  • Adverse drug reaction experienced by the patient
  • Complications experienced by the patient
  • Other pharmacovigilance relevant information (OPRI)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complete Reversal

    Time frame: 24 hrs

    Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema

  2. Complete Reversal

    Time frame: 48 hrs

    Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema

Secondary outcomes

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

    Time frame: HE Grade shift at 24 hrs and HE Grade shift at 48 hrs

    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=<grade 2 as per West-Haven criteria where grade 0 is Normal, Grade 1 is Mild lack of awareness, Grade 2 is Lethargic, Grade 3 is Somnolent but arousable and Grade 4 is Coma

  2. Time to Complete Reversal

    Time frame: up to 48 hrs

    Time to complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) HE after administration of lactulose retention enema

  3. Mortality

    Time frame: within 48 hrs

    Mortality in patients treated with lactulose retention enema

Other outcomes

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

    Time frame: Chart Review of Events over 48 Hour Period

    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.

  2. Reduction in Blood Ammonia Level

    Time frame: reported at 48 hrs

    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

  3. Duration of Hospital Stay

    Time frame: upto 30 days of hospital admission

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2015
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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