Hepatic Encephalopathy
Conditions
Brief summary
Acute liver failure in cirrhotic patients is associated with a one-month mortality of 48%. Encephalopathy, largely related to hyperammonemia, is a frequent complication of liver failure and is a poor prognostic marker. Lactulose decreases ammonia by acidification of the colon, replacement of urease-producing bacteria and creation of a laxative effect. Thus, the administration of lactulose in patients with severe hepatic encephalopathy reduces mortality by more than 40%. In intensive care patients, lactulose is often administered rectally. The use of simple rectal tubes is associated with frequent leakage of lactulose as well as faecal discharge and therefore risks of infection and skin lesions. Balloon rectal tubes with a drug delivery valve have recently been developed and used in this indication. The aim of this study is therefore to describe the use of these balloon rectal tubes to administer Lactulose in severe hepatic encephalopathy. This suggests that ammonia reduction in these patients may prolong survival time. No studies have described the administration of Lactulose via the rectal route with a balloon tube. The descriptive methodology is therefore appropriate. This is a preliminary study allowing data collection to establish the methodology for a subsequent clinical trial.
Interventions
None listed
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years * Patients treated with Lactulose with balloon rectal probe
Exclusion criteria
* Patient(s) objecting to the use of their data for research purposes * Rectal probe contraindication: damage to the rectal mucosa, rectal surgery, severe haemorrhoids, rectal stenosis, rectal tumour, * Lactulose contraindication (person unable to absorb galactose) * Patients deprived of liberty, under guardianship or curators * Pregnant women * Patient not affiliated to a social security scheme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe ammonia during lactulose administration by balloon rectal tube | 48 hours | Variation of ammonia before treatment and after 48h of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe ammonia levels after lactulose administration via balloon rectal tube. | at 7 days | Change in ammonia over 1 week in µmol/l after administration |
| Describe the skin tolerance of patients during hospitalization. | at 7 days | Percentage of patients with at least one pressure sore or infection in the lumbar, pelvic, buttocks, or buttock area |
| Describe complications related to the balloon rectal tube | at 7 days | Percentage of patients with at least one of the following complications: leakage of faeces during or after use of the catheter; rectal bleeding; peri-anal skin damage (fissure, ulcer, infection); bowel obstruction; bowel perforation, rectal pain, abdominal distension. |
| Describe the neurological course following administration of lactulose via a balloon rectal tube | at 7 days | Score Richmond Agitation-Sedation Scale from the minimum value -4 to maximum value + 4 Richmond Agitation and sedation scale , agitation |
| Patient outcomes | at 28 days | Duration of invasive ventilation, duration of resuscitation or intensive care, duration of hospital stay, mortality |
| Caregiver satisfaction | at 7 days | Anonymised use and maintenance satisfaction questionnaire into 0 is the worst score and 10 is the better score |
| Describe balloon rectal probe retention | at 7 days | Frequency of leakage during and within one hour of lactulose administration when the rectal probe balloon is inflated |
| Describe complications related to rectal lactulose administration | at 7 days | Percentage of patients with at least one of the following complications: hypernatremia \> 150 mmol/L, dehydration, renal insufficiency urea creatinemia. |
Countries
France
Outcome results
None listed