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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Describe ammonia during lactulose administration by balloon rectal tube | Variation of ammonia before treatment and after 48h of treatment | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the neurological course following administration of lactulose via a balloon rectal tube | Score Richmond Agitation-Sedation Scale from the minimum value -4 to maximum value + 4 Richmond Agitation and sedation scale , agitation | at 7 days |
| Describe ammonia levels after lactulose administration via balloon rectal tube. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with severe hepatic encephalopathy hospitalised in intensive care
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| Name | Affiliation | Role |
|---|---|---|
| Pierre BOUZAT, recruting | CENTRE HOSPITALIER UNIVERSITAIRE GRENOBLE ALPES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr PIERRE BOUZAT | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10051463 | Result | 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. | |
| 30703853 | Result | 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. |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Change in ammonia over 1 week in µmol/l after administration |
| at 7 days |
| Describe the skin tolerance of patients during hospitalization. | Percentage of patients with at least one pressure sore or infection in the lumbar, pelvic, buttocks, or buttock area | at 7 days |
| Describe complications related to the balloon rectal tube | Percentage of patients with at least one of the following complications: leakage of faeces during or after use of the catheter; rectal bleeding; peri-anal skin damage (fissure, ulcer, infection); bowel obstruction; bowel perforation, rectal pain, abdominal distension. | at 7 days |
| Describe complications related to rectal lactulose administration | Percentage of patients with at least one of the following complications: hypernatremia > 150 mmol/L, dehydration, renal insufficiency urea creatinemia. | at 7 days |
| Patient outcomes | Duration of invasive ventilation, duration of resuscitation or intensive care, duration of hospital stay, mortality | at 28 days |
| Caregiver satisfaction | Anonymised use and maintenance satisfaction questionnaire into 0 is the worst score and 10 is the better score | at 7 days |
| Describe balloon rectal probe retention | Frequency of leakage during and within one hour of lactulose administration when the rectal probe balloon is inflated | at 7 days |
| 28012068 | Result | 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. |
| 26654994 | Result | 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. |
| 27132633 | Result | 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. |
| 16024550 | Result | 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. |
| 17685471 | Result | 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. |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |