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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003376-21 | EudraCT Number | ||
| PI07 - 0641 | Other Grant/Funding Number | FIS (Instituto de Salud Carlos III) |
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The purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.
Hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated with poor prognosis. The most common presentation is an acute episode of hepatic encephalopathy precipitated by factors that increase the exposure of the brain to ammonia. Current therapies are based on measures that decrease plasma ammonia and counteract the effect of factors such as infection or electrolyte's disturbances. Brain edema and abnormalities of cerebral blood flow appear to be important. Part of the impairment of astrocyte function could be related to an increase of oxidative stress injury.
In patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma is usually low. Administration of human albumin in patients with hepatorenal syndrome and spontaneous bacterial peritonitis has a major impact on the prognosis of these complications. Albumin prevents circulatory dysfunction and renal failure. The mechanisms of action may include the maintenance of oncotic pressure and a scavenger effect of toxic substances present in blood. Albumin has also shown beneficial effects in neurological injury secondary to stroke, probably in relation to this scavenger effect.
The administration of intravenous albumin to patients with hepatic encephalopathy may have beneficial effects on the course of encephalopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Drug | Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients without hepatic encephalopathy | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of encephalopathy assessed by CHESS and West-Haven | Admission to the hospital (up to day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Cordoba, MD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc Tauli | Sabadell | Barcelona | Spain | |||
| Hospital de Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23872605 | Derived | Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19. |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| Sodium chloride 0.9% |
| Drug |
Day 0: 400-600 ml. Day 2: 200-400 ml. |
|
| Barcelona |
| 08025 |
| Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic | Barcelona | 08036 | Spain |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |