Effect of albumin infusion on albumin functio

Phase 1

Conditions: refractory ascites, spontaneous bacterial peritonitis, hepatorenal syndrome
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-004012-35-AT

Lead Sponsor: Medical University of Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Routine indication for albumin infusion (hepatorenal syndrome, spontaneous bacterial peritonitis, large-volume paracentesis)
- Age >18 years
- Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Malignant ascites
- Presence of hepatocellular carcinoma or advanced extrahepatic neoplasia
- Nephrotic syndrome
- Albumin infusion >80g within the last 48 hours
- Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate the effect of albumin infusion on oxidative<br>albumin modification, on plasma thiol status and on albumin binding capacity for DS<br>in patients who routinely receive albumin infusion for various indications and to relate these findings with neurohumoral parameters.<br>We expect that albumin improves oxidation state of circulating albumin as well as<br>albumin function estimated by DS binding capacity.<br>;Secondary Objective: not applicable;Primary end point(s): Albumin binding capacity for dansylsarcosine (DS);Timepoint(s) of evaluation of this end point: 0h (baseline), 24h, 48h

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Redox state of albumin (HMA/HNA1/HNA2)<br>- Plasma thiol status<br>- Neurohumoral parameters (PRC, PCC);Timepoint(s) of evaluation of this end point: 0h (baseline), 24h, 48h