Trial Outcomes & Findings for 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] (NCT NCT02377947)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

24 hrs

Results posted on

2020-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.38 years STANDARD_DEVIATION 10.18 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment India	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Complete Reversal	80 percentage of participants Interval 66.3 to 90.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Complete Reversal	90 percentage of participants Interval 78.2 to 96.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours shift from HE Grade 3 to <2 after 24 hours	86.67 percentage of participants
Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours shift from HE Grade 4 to <2 after 24 hours	20.0 percentage of participants
Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours shift from HE Grade 3 to <2 after 48 hours	95.56 percentage of participants
Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours shift from HE Grade 4 to <2 after 48 hours	40.0 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Time to Complete Reversal	25.39 Hours Standard Deviation 8.85

SECONDARY outcome

Timeframe: within 48 hrs

Mortality in patients treated with lactulose retention enema

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Mortality	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).	5 number of events

OTHER_PRE_SPECIFIED outcome

Timeframe: reported at 48 hrs

Population: The ammonia levels were available at baseline for 28 patients where as the last observed blood ammonia level after administration of lactulose enema was available for 4 patients. Thus the change from baseline was calculated for 4 patients. The Change value = Visit value - Baseline Value

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

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=4 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Reduction in Blood Ammonia Level	-70.6 Mcg/DL Standard Deviation 11.32

OTHER_PRE_SPECIFIED outcome

Timeframe: upto 30 days of hospital admission

Outcome measures

Outcome measures
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 Participants Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Duration of Hospital Stay	229.4 hours Standard Deviation 147.64

Adverse Events

Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With Cirrhosis (Grade 3 & 4 Per West Haven cr.) n=50 participants at risk Patients with cirrhosis having grade 3 or grade 4 (West Haven Criteria) hepatic encephalopathy who were treated with Lactulose retention enema
Gastrointestinal disorders Diarrhea and Abdominal discomfort	2.0% 1/50 • Number of events 2 As this study was a retrospective chart review of 50 patients who were treated with lactulose enema, only (S)ADRs and complications were collected. Thus, the total of participants at risk were 50 for ADRs and 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.
Gastrointestinal disorders Abdominal fullness and discomfort	2.0% 1/50 • Number of events 2 As this study was a retrospective chart review of 50 patients who were treated with lactulose enema, only (S)ADRs and complications were collected. Thus, the total of participants at risk were 50 for ADRs and 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.
Injury, poisoning and procedural complications Mild rectal bleed	2.0% 1/50 • Number of events 1 As this study was a retrospective chart review of 50 patients who were treated with lactulose enema, only (S)ADRs and complications were collected. Thus, the total of participants at risk were 50 for ADRs and 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.

Additional Information

Dr. Shubhangi Desai

Abbott

Phone: +91 22 7175 7408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place