Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021360-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".
The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure", renal disfunction, cerebral disfunction ,and inflamtory response
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin | Other | Albumin solution for infusion 5%. dosage: 43,5 millimole intravenouse use , 6 plasma exchange with albumin in 11 days and administration of polyclonal gamma globulin.6 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma exchange with albumin | Procedure | Realization of 6 plasma exchange with albumin in 11 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albumin functional capacity | Albumin binding capacity | 10 days |
| Albumin functional capacity | Electron Paramagnetic Resonance Spectroscopy | 10 days |
| Albumin functional capacity | Ischemia-modified albumin | 10 days |
| Circulatory disfunction | Plasma renin activity | 10 days |
| Circulatory disfunction | Plasma concentration of noradrenaline | 10 days |
| Circulatory disfunction | Systemic hemodynamic study and portal venous pressure | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of blood urea nitrogen | 1 month | |
| Hepatic encephalopathy graded with the West Haven Criteria | 1 month | |
| Hepatic function parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vicente Arroyo, MD | Hospital ClÃnic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic of Barcelona | Barcelona | 08028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38544553 | Derived | Fernandez J, Lozano M, Torres M, Horrillo R, Afonso N, Nunez L, Mestre A, Perez A, Cid J, Costa M, Arroyo V, Paez A. Effect of plasma exchange with albumin replacement on albumin functionality and organ dysfunction in acute-on-chronic liver failure. JHEP Rep. 2024 Jan 22;6(4):101017. doi: 10.1016/j.jhepr.2024.101017. eCollection 2024 Apr. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Conventional hepatic function parameters: aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, alkaline phosphatase, total, conjugated and not conjugated serum bilirubin, serum albumin, international normalized ratio (INR) and prothrombin index |
| 1 month |
| Plasma concentration of serum creatinine | 1 month |
| Plasma concentration of sodium | 1 month |
| Plasma concentration of potassium | 1 month |
| Plasma concentration of phosphorus | 1 month |
| hepatic toxins | Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum. | 10 days |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D017093 | Liver Failure |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |
Not provided
Not provided
| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided