NCT06248736

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-08-27
• Completion: 2024-08-27
• First posted: 2024-02-08
• Last updated: 2025-02-13

Locations

1 site across 1 country: France