Minimal Hepatic Encephalopathy
Conditions
Keywords
encephalopathy, pediatric liver disease, pediatric cirrhosis, serum ammonia levels
Brief summary
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
Detailed description
In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.
Interventions
DRUGLactulose
1.5cc/kg/day po for three months
DRUGplacebo
1.5 ml sugar water/kg day for three months
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
Exclusion criteria
* patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function. * patients with known hearing or vision difficulties. * those patients who do not speak English will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | baseline | failure of one cognitive function test indicates presence of MHE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQOL) | baseline | HRQOL administered to parents prior to treatment |
| Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function | before and after each treatment period | MHE as measured by failure of one or more cognitive test |
Countries
United States
Participant flow
Recruitment details
Informed consent was obtained on the first subject 1/16/2009 and recruitment continued until study closure in November 2010.
Pre-assignment details
Two subjects were withdrawn prior to randomization.Two did not meet entry criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Participants all aprticipants who were randomized to receive treatment | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
failure of one cognitive function test indicates presence of MHE
Time frame: baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Randomized Participants | Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | 6 participant |
Secondary
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
MHE as measured by failure of one or more cognitive test
Time frame: before and after each treatment period
Population: data not collected as planned
Secondary
Health Related Quality of Life (HRQOL)
HRQOL administered to parents prior to treatment
Time frame: baseline
Population: data not collected as planned