Clinical trial NCT06248736: Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy
Official title: Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Encephalopathy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with severe hepatic encephalopathy hospitalised in intensive care

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.


Eligibility criteria: 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

Primary outcomes:
measure: Describe ammonia during lactulose administration by balloon rectal tube
timeFrame: 48 hours
Secondary outcomes:
measure: Describe the neurological course following administration of lactulose via a balloon rectal tube
timeFrame: at 7 days
measure: Describe ammonia levels after lactulose administration via balloon rectal tube.
timeFrame: at 7 days
measure: Describe the skin tolerance of patients during hospitalization.
timeFrame: at 7 days
measure: Describe complications related to the balloon rectal tube
timeFrame: at 7 days
measure: Describe complications related to rectal lactulose administration
timeFrame: at 7 days
measure: Patient outcomes
timeFrame: at 28 days
measure: Caregiver satisfaction
timeFrame: at 7 days
measure: Describe balloon rectal probe retention
timeFrame: at 7 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Pr PIERRE BOUZAT
Study officials:
affiliation: CENTRE HOSPITALIER UNIVERSITAIRE GRENOBLE ALPES
name: Pierre BOUZAT, recruting
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bernal W, Hall C, Karvellas CJ, Auzinger G, Sizer E, Wendon J. Arterial ammonia and clinical risk factors for encephalopathy and intracranial hypertension in acute liver failure. Hepatology. 2007 Dec;46(6):1844-52. doi: 10.1002/hep.21838.