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.

Sponsor:

Collaborator:

Hospital Clinic of Barcelona

Information provided by (Responsible Party):

Joan Albert Arnaiz, Instituto Grifols, S.A.

ClinicalTrials.gov Identifier:

NCT00968695

First received: August 28, 2009

Last updated: November 6, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 28, 2009

Last Updated Date

November 6, 2012

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00968695 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

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.

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Cirrhosis
Ascites

Intervention ^ICMJE

Drug: Albumin

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.

Study Arm (s)

Experimental: Albumin

Intervention: Drug: Albumin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Joan Albert Arnaiz, MD	0034932279838	jaarnaiz@clinic.ub.es
Contact: Laura Núnez, M Sc	0034935710700	laura.nunez@grifols.com

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00968695

Other Study ID Numbers ^ICMJE

IG0802

Has Data Monitoring Committee

Responsible Party

Joan Albert Arnaiz, Instituto Grifols, S.A.

Study Sponsor ^ICMJE

Joan Albert Arnaiz

Collaborators ^ICMJE

Hospital Clinic of Barcelona

Investigators ^ICMJE

Principal Investigator:

Vicente Arroyo, MD

Hospital Clínic of Barcelona

Information Provided By

Instituto Grifols, S.A.

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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