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.
Study Type
OBSERVATIONAL
Enrollment
25
Pr PIERRE BOUZAT
Grenoble, France
Describe ammonia during lactulose administration by balloon rectal tube
Variation of ammonia before treatment and after 48h of treatment
Time frame: 48 hours
Describe the neurological course following administration of lactulose via a balloon rectal tube
Score Richmond Agitation-Sedation Scale from the minimum value -4 to maximum value + 4 Richmond Agitation and sedation scale , agitation
Time frame: at 7 days
Describe ammonia levels after lactulose administration via balloon rectal tube.
Change in ammonia over 1 week in µmol/l after administration
Time frame: at 7 days
Describe the skin tolerance of patients during hospitalization.
Percentage of patients with at least one pressure sore or infection in the lumbar, pelvic, buttocks, or buttock area
Time frame: at 7 days
Describe complications related to the balloon rectal tube
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.
Time frame: at 7 days
Describe complications related to rectal lactulose administration
Percentage of patients with at least one of the following complications: hypernatremia \> 150 mmol/L, dehydration, renal insufficiency urea creatinemia.
Time frame: at 7 days
Patient outcomes
Duration of invasive ventilation, duration of resuscitation or intensive care, duration of hospital stay, mortality
Time frame: at 28 days
Caregiver satisfaction
Anonymised use and maintenance satisfaction questionnaire into 0 is the worst score and 10 is the better score
Time frame: at 7 days
Describe balloon rectal probe retention
Frequency of leakage during and within one hour of lactulose administration when the rectal probe balloon is inflated
Time frame: at 7 days
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