Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy
NCT ID: NCT06248736
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
25 participants
OBSERVATIONAL
2022-06-07
2024-08-27
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients treated with Lactulose with balloon rectal probe
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Pierre BOUZAT, recruting
Role: PRINCIPAL_INVESTIGATOR
CENTRE HOSPITALIER UNIVERSITAIRE GRENOBLE ALPES
Locations
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Pr PIERRE BOUZAT
Grenoble, , France
Countries
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References
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Clemmesen JO, Larsen FS, Kondrup J, Hansen BA, Ott P. Cerebral herniation in patients with acute liver failure is correlated with arterial ammonia concentration. Hepatology. 1999 Mar;29(3):648-53. doi: 10.1002/hep.510290309.
Shalimar, Sheikh MF, Mookerjee RP, Agarwal B, Acharya SK, Jalan R. Prognostic Role of Ammonia in Patients With Cirrhosis. Hepatology. 2019 Sep;70(3):982-994. doi: 10.1002/hep.30534. Epub 2019 Mar 21.
Dasarathy S, Mookerjee RP, Rackayova V, Rangroo Thrane V, Vairappan B, Ott P, Rose CF. Ammonia toxicity: from head to toe? Metab Brain Dis. 2017 Apr;32(2):529-538. doi: 10.1007/s11011-016-9938-3. Epub 2016 Dec 24.
Jalan R, De Chiara F, Balasubramaniyan V, Andreola F, Khetan V, Malago M, Pinzani M, Mookerjee RP, Rombouts K. Ammonia produces pathological changes in human hepatic stellate cells and is a target for therapy of portal hypertension. J Hepatol. 2016 Apr;64(4):823-33. doi: 10.1016/j.jhep.2015.11.019. Epub 2015 Dec 2.
Ravi S, Bade KS, Hasanin M, Singal AK. Ammonia level at admission predicts in-hospital mortality for patients with alcoholic hepatitis. Gastroenterol Rep (Oxf). 2017 Aug;5(3):232-236. doi: 10.1093/gastro/gow010. Epub 2016 May 1.
Bhatia V, Singh R, Acharya SK. Predictive value of arterial ammonia for complications and outcome in acute liver failure. Gut. 2006 Jan;55(1):98-104. doi: 10.1136/gut.2004.061754. Epub 2005 Jul 15.
Bernal W, Hall C, Karvellas CJ, Auzinger G, Sizer E, Wendon J. Arterial ammonia and clinical risk factors for encephalopathy and intracranial hypertension in acute liver failure. Hepatology. 2007 Dec;46(6):1844-52. doi: 10.1002/hep.21838.
Other Identifiers
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CHU Grenoble/ ALPACA
Identifier Type: -
Identifier Source: org_study_id
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