Hepatic EncephalopathyNCT02377947
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]
An observational study of Hepatic Encephalopathy, run by Abbott at 3 sites in India.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy
- How many people
- 50 participants
- Where
- 3 sitesIndia
- Study dates
- Dec 2015to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective study - data charts of the cirrhotic patients having grade III and IV and who were administered lactulose enema will be reviewed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
India3 sites
Medanta Hospital
Gūrgaon, 122001
Research facility ORG-000333
Gūrgaon, 122001
Sir Ganga Ram Hospital
New Delhi, 110060
About this 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.
Read the detailed description
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)
- Conditions
- Hepatic Encephalopathy
- Keywords
- Lactulose Retention Enema, Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria, The Retro Study
- Medical subject headings
- Hepatic Encephalopathy, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 48 hrs
Secondary outcomes (3)
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=<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
Measured: HE Grade shift at 24 hrs and HE Grade shift at 48 hrs
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
Measured: up to 48 hrs
Mortality
Mortality in patients treated with lactulose retention enema
Measured: within 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dyotona Roy-Sengupta, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377947
- Sponsor's protocol ID
- EPIDJ001
- Other IDs
- REF/2014/11/007981
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2015
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT02377947
- Acronym / sponsor ID
- EPIDJ001
- Conditions
- Hepatic Encephalopathy
- Keywords
- Lactulose Retention Enema, Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria, The Retro Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective study - data charts of the cirrhotic patients having grade III and IV and who were administered lactulose enema will be reviewed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
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
Time to Complete Reversal
Time frame: up to 48 hrs
Mortality
Time frame: within 48 hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dyotona Roy-Sengupta study chair
Abbott
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy, run by Abbott at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Reversal (time frame: 24 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.