Effect of albumin infusion on albumin function

Effect of albumin infusion on oxidative albumin modification, albumin binding capacity and plasma thiol status

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004012-35-AT

Enrollment

Unknown

Registered

2016-12-14

Start date

2017-01-13

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory ascites, spontaneous bacterial peritonitis, hepatorenal syndrome

Interventions

Trade Name: Albunorm 200 g/l Infusionslösung Pharmaceutical Form: Infusion INN or Proposed INN: HUMAN ALBUMIN SOLUTION 20% Other descriptive name: HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

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

Primary

Measure	Time frame
Main Objective: The aim of this study is to investigate the effect of albumin infusion on oxidative albumin modification, on plasma thiol status and on albumin binding capacity for DS in patients who routinely receive albumin infusion for various indications and to relate these findings with neurohumoral parameters. We expect that albumin improves oxidation state of circulating albumin as well as albumin function estimated by DS binding capacity. ;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	—

Measure

Time frame

Main Objective: The aim of this study is to investigate the effect of albumin infusion on oxidative albumin modification, on plasma thiol status and on albumin binding capacity for DS in patients who routinely receive albumin infusion for various indications and to relate these findings with neurohumoral parameters. We expect that albumin improves oxidation state of circulating albumin as well as albumin function estimated by DS binding capacity. ;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

—

Countries

Austria

Contacts

Public ContactSilke Pohl

Division of Gastroenterology and Hepatology

silke.pohl@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026