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Completed

NCT Number: NCT06248736

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pr PIERRE BOUZAT

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Describe ammonia during lactulose administration by balloon rectal tube

    Time frame: 48 hours

    Variation of ammonia before treatment and after 48h of treatment

Secondary outcomes

  1. Describe the neurological course following administration of lactulose via a balloon rectal tube

    Time frame: at 7 days

    Score Richmond Agitation-Sedation Scale from the minimum value -4 to maximum value + 4 Richmond Agitation and sedation scale , agitation

  2. Describe ammonia levels after lactulose administration via balloon rectal tube.

    Time frame: at 7 days

    Change in ammonia over 1 week in µmol/l after administration

  3. Describe the skin tolerance of patients during hospitalization.

    Time frame: at 7 days

    Percentage of patients with at least one pressure sore or infection in the lumbar, pelvic, buttocks, or buttock area

  4. Describe complications related to the balloon rectal tube

    Time frame: 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.

  5. Describe complications related to rectal lactulose administration

    Time frame: at 7 days

    Percentage of patients with at least one of the following complications: hypernatremia > 150 mmol/L, dehydration, renal insufficiency urea creatinemia.

  6. Patient outcomes

    Time frame: at 28 days

    Duration of invasive ventilation, duration of resuscitation or intensive care, duration of hospital stay, mortality

  7. Caregiver satisfaction

    Time frame: at 7 days

    Anonymised use and maintenance satisfaction questionnaire into 0 is the worst score and 10 is the better score

  8. Describe balloon rectal probe retention

    Time frame: at 7 days

    Frequency of leakage during and within one hour of lactulose administration when the rectal probe balloon is inflated

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: ALPACA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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