Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy

Completed

• Conditions: Hepatic Encephalopathy

• Registration Number: NCT06248736
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-08
• Primary Completion: 2024-08-27
• Study Completion: 2024-08-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe ammonia during lactulose administration by balloon rectal tube	48 hours	Variation of ammonia before treatment and after 48h of treatment

Secondary Outcome Measures

Name	Time	Method
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 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
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 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.
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

Trial Locations

Locations (1)

Pr PIERRE BOUZAT; 🇫🇷 Grenoble, France