Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248736
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-11-14
Brief Title:
Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPACA
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None