CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06248736
NCT06248736N/ACompleted

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

University Hospital, Grenoble·observational·Posted Feb 8, 2024·Updated Feb 13, 2025

In Brief

An observational study for Hepatic Encephalopathy. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 8, 2024
Enrollment StartJun 7, 2022
Primary CompletionAug 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 2.4 years ago