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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]

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ClinicalTrials.gov Identifier: NCT02377947
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott

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.

Condition or disease
Hepatic Encephalopathy

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)

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Other
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]
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose

Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377947


Locations
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India
Medanta Hospital
Gurgaon, India, 122001
Research facility ORG-000333
Gurgaon, India, 122001
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Abbott
Investigators
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Study Chair: Dyotona Roy-Sengupta Abbott
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02377947    
Other Study ID Numbers: EPIDJ001
REF/2014/11/007981 ( Registry Identifier: Clinical Trial registry of India )
First Posted: March 4, 2015    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: February 2020
Keywords provided by Abbott:
Lactulose Retention Enema
Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria
The Retro Study
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases