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
| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
Not provided
Not provided
Not provided
Not provided
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin | Experimental | The subjects will be receiving albumin 20% infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Drug | The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin. |
| Measure | Description | Time Frame |
|---|---|---|
| To asses change from Baseline plasma renin concentration at Week 14 | Plasma renin activity will be measured at Baseline and Week 14 | 14 weeks |
| To asses change from Baseline plasma renin concentration at Week 20 | Plasma renin activity will be measured at Baseline and Week 20 | 20 weeks |
| To asses change from Baseline plasma concentration of noradrenaline at week 14 | Plasma noradrenaline concentration will be measured at Baseline and Week 14 | 14 weeks |
| To asses change from Baseline plasma concentration of noradrenaline at Week 20 | Plasma noradrenaline concentration will be measured at Baseline and Week 20 | 20 weeks |
| To assess change from Baseline glomerular filtration rate at Week 14 | Glomerular filtration rate will be measured at Baseline and Week 14 | 14 weeks |
| To assess change from Baseline glomerular filtration rate at Week 20 | Glomerular filtration rate will be measured at Baseline and Week 20 | 20 weeks |
| To assess change from Baseline cardiac output at Week 14 | Cardiac output will be measured at Baseline and Week 14 | 14 weeks |
| To assess change from Baseline cardiopulmonary pressures at Week 14 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vicente Arroyo, MD | Hospital Clínic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30905652 | Derived | Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Cardiopulmonary pressures will be measured at Baseline and Week 14 |
| 14 weeks |
| To assess change from Baseline free hepatic pressure at Week 14 | Free hepatic pressure will be measured at Baseline and Week 14 | 14 weeks |
| To assess change from Baseline wedged hepatic pressure at Week 14 | Wedged hepatic pressure will be measured at Baseline and Week 14 | 14 weeks |
| To assess change from Baseline echocardiography at Week 14 | Echocardiography will be measured at Baseline and Week 14 | 14 weeks |
| Barcelona |
| 08003 |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Clínic of Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |