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

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06248736
Study type Observational
Source University Hospital, Grenoble
Contact Pr BOUZAT
Phone 0476766729
Email pbouzat@chu-grenoble.fr
Status Recruiting
Phase
Start date June 7, 2022
Completion date December 31, 2024
View Details
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