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.
This study is currently recruiting participants.
Verified November 2012 by Instituto Grifols, S.A.
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Joan Albert Arnaiz, Instituto Grifols, S.A.
First received: August 28, 2009
Last updated: November 6, 2012
Last verified: November 2012
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.
||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- To asses plasma renin activity and plasma concentration of noradrenaline [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
- Glomerular filtration [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Portal hypertension [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Cardiac Function [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
The pattern of administration of 20% human albumin is 1'5g/kg every week to infuse in 6 hours with a minimum of 90 g up to 150 g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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, BUN ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968695
|Hospital Universitari Germans Trias i Pujol
|Badalona, Barcelona, Spain, 08916 |
|Hospital Clínic of Barcelona
|Barcelona, Spain, 08036 |
|Contact: Vicente Arroyo, MD 0034932275739 email@example.com |
|Contact: Javier Fernández, MD 0034932275739 firstname.lastname@example.org |
|Hospital de la Santa Creu i Sant Pau
|Barcelona, Spain, 08025 |
|Hospital del Mar
|Barcelona, Spain, 08003 |
|Hospital Universitario Ramón y Cajal
|Madrid, Spain, 28034 |
|Contact: Luis Ruiz del Árbol, MD |
|Hospital Universitario Gregorio Marañón
|Madrid, Spain, 28007 |
Joan Albert Arnaiz
Hospital Clinic of Barcelona
||Vicente Arroyo, MD
||Hospital Clínic of Barcelona
No publications provided
||Joan Albert Arnaiz, Project manager, Instituto Grifols, S.A.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 28, 2009
||November 6, 2012
||Spain: Spanish Agency of Medicines
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Digestive System Diseases