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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.

Information source: Instituto Grifols, S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis; Ascites

Intervention: Albumin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Joan Albert Arnaiz

Official(s) and/or principal investigator(s):
Vicente Arroyo, MD, Principal Investigator, Affiliation: Hospital Clínic of Barcelona

Summary

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.

Clinical Details

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 design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To asses plasma renin activity and plasma concentration of noradrenaline

Glomerular filtration

Portal hypertension

Cardiac Function

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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, BUN ≥ 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.

Locations and Contacts

Hospital Clínic of Barcelona, Barcelona 08036, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain

Hospital del Mar, Barcelona 08003, Spain

Hospital Universitario Gregorio Marañón, Madrid 28007, Spain

Hospital Universitario Ramón y Cajal, Madrid 28034, Spain

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona 08916, Spain

Additional Information

Starting date: July 2009
Last updated: April 14, 2015

Page last updated: August 23, 2015

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