CClinicalTrials.gg
Sign In
CompletedNCT02377947Updated Feb 10, 2020Results posted

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 in Hepatic Encephalopathy, sponsored by Abbott. Completed at 3 sites in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Abbott · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Hepatic Encephalopathy

Keywords

  • Lactulose Retention Enema
  • Hepatic Encephalopathy, Grade 3 or 4 West Haven Criteria
  • The Retro Study
03

In context

Hepatic Encephalopathy

218 studies on the registry are indexed under Hepatic Encephalopathy; 48 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 56 observational studies indexed under Hepatic Encephalopathy.

Browse Hepatic Encephalopathy studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hrs

  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

    Time frame: 48 hrs

Secondary outcomes

  1. 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

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

  2. 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

    Time frame: up to 48 hrs

  3. Mortality

    Mortality in patients treated with lactulose retention enema

    Time frame: within 48 hrs

Other outcomes

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

    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.

    Time frame: Chart Review of Events over 48 Hour Period

  2. Reduction in Blood Ammonia Level

    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

    Time frame: reported at 48 hrs

  3. Duration of Hospital Stay

    Time frame: upto 30 days of hospital admission

07

Results

Posted Feb 10, 2020

Participant flow

Participant flow — Overall Study
MilestonePatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Started50
Completed50
Not completed0

Outcome measures

PrimaryComplete 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

Time frame:
24 hrs
Reported as:
Number · percentage of participants
Complete Reversal
percentage of participantsPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Complete Reversal80 (66.3 to 90.0)
PrimaryComplete 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

Time frame:
48 hrs
Reported as:
Number · percentage of participants
Complete Reversal
percentage of participantsPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Complete Reversal90 (78.2 to 96.7)
SecondaryHepatic 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

Time frame:
HE Grade shift at 24 hrs and HE Grade shift at 48 hrs
Reported as:
Number · percentage of participants
Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours
percentage of participantsPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
shift from HE Grade 3 to <2 after 24 hours86.67
shift from HE Grade 4 to <2 after 24 hours20.0
shift from HE Grade 3 to <2 after 48 hours95.56
shift from HE Grade 4 to <2 after 48 hours40.0
SecondaryTime to Complete Reversal

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

Time frame:
up to 48 hrs
Reported as:
Mean · Hours
Time to Complete Reversal
HoursPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Time to Complete Reversal25.39 ± 8.85
SecondaryMortality

Mortality in patients treated with lactulose retention enema

Time frame:
within 48 hrs
Reported as:
Count of participants · Participants
Mortality
ParticipantsPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Mortality0
Other pre-specifiedSafety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).

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.

Time frame:
Chart Review of Events over 48 Hour Period
Reported as:
Number · number of events
Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).
number of eventsPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).5
Other pre-specifiedReduction in Blood Ammonia Level

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

Time frame:
reported at 48 hrs
Reported as:
Mean · Mcg/DL
Reduction in Blood Ammonia Level
Mcg/DLPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Reduction in Blood Ammonia Level-70.6 ± 11.32
Other pre-specifiedDuration of Hospital Stay
Time frame:
upto 30 days of hospital admission
Reported as:
Mean · hours
Duration of Hospital Stay
hoursPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Duration of Hospital Stay229.4 ± 147.64

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)6/50 (12%)0/50 (0%)3/50 (6%)
Most frequent other events
Most frequent other events
EventPatients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Diarrhea and Abdominal discomfortGastrointestinal disorders1/50
Abdominal fullness and discomfortGastrointestinal disorders1/50
Mild rectal bleedInjury, poisoning and procedural complications1/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
<=18 years0
Between 18 and 65 years50
>=65 years0
Age, Continuous
Age, Continuous(years)Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Mean48.38 ± 10.18
Sex: Female, Male
Sex: Female, Male(Participants)Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
Female10
Male40
Region of Enrollment
Region of Enrollment(Participants)Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)
India50
08

Study locations

3 sites
  • Medanta Hospital
    Gurgaon, 122001, India
  • Research facility ORG-000333
    Gurgaon, 122001, India
  • Sir Ganga Ram Hospital
    New Delhi, 110060, India
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02377947
Lead sponsor
Abbott
Responsible party
Sponsor
First posted
Mar 4, 2015
Start date
Dec 2015
Primary completion
Mar 2016
Completion
Mar 2016
Results posted
Feb 10, 2020
Last update
Feb 10, 2020

Study contacts

Dyotona Roy-Sengupta
study chair · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatic Encephalopathy→

Other studies from this sponsor

Abbott

Start the discussion