Clinical trial NCT00968695: Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
Official title: Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Ascites
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2009-08-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years and less than 80 years.
* Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
* Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
* Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.

Exclusion Criteria:

* Refractory Ascites (paracentesis requirements over 1 month.
* Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule\> 5 cm or three nodules\> 3 cm).
* History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
* Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
* Heart failure or structural heart disease.
* Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).
* Moderate or severe lung chronic disease.
* Transplant.
* Infection with human immunodeficiency virus.
* Active addiction to drugs.
* Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.
* Pregnancy.

Primary outcomes:
measure: To asses change from Baseline plasma renin concentration at Week 14
timeFrame: 14 weeks
measure: To asses change from Baseline plasma renin concentration at Week 20
timeFrame: 20 weeks
measure: To asses change from Baseline plasma concentration of noradrenaline at week 14
timeFrame: 14 weeks
measure: To asses change from Baseline plasma concentration of noradrenaline at Week 20
timeFrame: 20 weeks
measure: To assess change from Baseline glomerular filtration rate at Week 14
timeFrame: 14 weeks
measure: To assess change from Baseline glomerular filtration rate at Week 20
timeFrame: 20 weeks
measure: To assess change from Baseline cardiac output at Week 14
timeFrame: 14 weeks
measure: To assess change from Baseline cardiopulmonary pressures at Week 14
timeFrame: 14 weeks
measure: To assess change from Baseline free hepatic pressure at Week 14
timeFrame: 14 weeks
measure: To assess change from Baseline wedged hepatic pressure at Week 14
timeFrame: 14 weeks
measure: To assess change from Baseline echocardiography at Week 14
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Hospital Clínic of Barcelona
name: Vicente Arroyo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.