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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cirrhosis Ascites

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albumin

The subjects will be receiving albumin 20% infusions

Group Type EXPERIMENTAL

Albumin

Intervention Type 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.

Interventions

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Albumin

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.

Intervention Type DRUG

Other Intervention Names

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Albutein 20%

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No