Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.

NCT00968695 | Completed Phase 4

• 1 other identifier: IG0802
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Cirrhosis; Ascites

Outcome Measures

Primary Outcomes (11)

• 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

  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

Study Arms (1)

Albumin

EXPERIMENTAL

The subjects will be receiving albumin 20% infusions

Drug: Albumin

Interventions

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.

Also known as: Albutein 20%

Albumin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (6)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clínic of Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

• 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.

  PMID: 30905652 DERIVED

MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Vicente Arroyo, MD

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)