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

• Sponsor: Instituto Grifols, S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00968695
• Collaborator: Hospital Clinic of Barcelona (Other)
• Enrollment: 33
• Locations: 6
• Arm: 1
• Actual Duration (Months): 57
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis; Ascites	Drug: Albumin	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albumin The subjects will be receiving albumin 20% infusions	Drug: 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.; Other Names: Albutein 20%

Outcome Measures

Primary Outcome Measures

1. To asses change from Baseline plasma renin concentration at Week 14 [14 weeks]

   Plasma renin activity will be measured at Baseline and Week 14

2. To asses change from Baseline plasma renin concentration at Week 20 [20 weeks]

   Plasma renin activity will be measured at Baseline and Week 20

3. To asses change from Baseline plasma concentration of noradrenaline at week 14 [14 weeks]

   Plasma noradrenaline concentration will be measured at Baseline and Week 14

4. To asses change from Baseline plasma concentration of noradrenaline at Week 20 [20 weeks]

   Plasma noradrenaline concentration will be measured at Baseline and Week 20

5. To assess change from Baseline glomerular filtration rate at Week 14 [14 weeks]

   Glomerular filtration rate will be measured at Baseline and Week 14

6. To assess change from Baseline glomerular filtration rate at Week 20 [20 weeks]

   Glomerular filtration rate will be measured at Baseline and Week 20

7. To assess change from Baseline cardiac output at Week 14 [14 weeks]

   Cardiac output will be measured at Baseline and Week 14

8. To assess change from Baseline cardiopulmonary pressures at Week 14 [14 weeks]

   Cardiopulmonary pressures will be measured at Baseline and Week 14

9. To assess change from Baseline free hepatic pressure at Week 14 [14 weeks]

   Free hepatic pressure will be measured at Baseline and Week 14

10. To assess change from Baseline wedged hepatic pressure at Week 14 [14 weeks]

    Wedged hepatic pressure will be measured at Baseline and Week 14

11. To assess change from Baseline echocardiography at Week 14 [14 weeks]

    Echocardiography will be measured at Baseline and Week 14

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	Hospital del Mar	Barcelona		Spain	08003
3	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
4	Hospital Clínic of Barcelona	Barcelona		Spain	08036
5	Hospital Universitario Gregorio Marañón	Madrid		Spain	28007
6	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

• Instituto Grifols, S.A.
• Hospital Clinic of Barcelona

Investigators

• Principal Investigator: Vicente Arroyo, MD, Hospital Clínic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto Grifols, S.A.
• ClinicalTrials.gov Identifier: NCT00968695
• Other Study ID Numbers: IG0802
• First Posted: Aug 31, 2009
• Last Update Posted: Jun 26, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Fibrosis; Ascites

Study Results

No Results Posted as of Jun 26, 2019