Effect of Albumin Infusion on Oxidative Albumin Modification, Albumin Binding Capacity and Plasma Thiol Status (ALB-INFUS)

March 3, 2025 updated by: Medical University of Graz
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, bacterial products such as endotoxin, and neutrophil function

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Albumin infusion has been shown to improve outcome in spontaneous bacterial peritonitis, to reverse hepatorenal syndrome combined with vasoconstrictors, and to prevent post-paracentesis circulatory dysfunction. These beneficial effects are associated with hemodynamic improvement reflected by neurohumoral changes such as a decrease in plasma renin activity .

Albumin is a multifunctional protein. Its biological functions include maintenance of oncotic pressure, solubilization and transport of hydrophobic substances, antioxidant function via its free sulfhydryl group at cysteine-34, metal binding at its N-terminus, immunomodulation and/or endothelial stabilization via binding and inactivation of endotoxin. Thus the beneficial effects of albumin infusion described above are probably not only due to plasma volume expansion but also to an improvement of various aspects of albumin function.

Albumin harbours two specific binding sites described by Sudlow: site I which binds large heterocyclic compounds and dicarboxylic acids (such as bilirubin) and site II which binds aromatic carboxylic compounds (such as benzodiazepines). Decreased binding of dansylsarcosine (DS) - a model ligand for the benzodiazepin binding site II - was found in patients with end-stage liver disease. Interestingly, extracorporeal albumin dialysis using the molecular adsorbents recirculating system (MARS) has been found to improve DS binding, while no such data exist for albumin infusion under the above-mentioned conditions.

Further examples for impaired albumin function in cirrhosis include alterations in fatty acid binding (as estimated by electron paramagnetic resonance) and impaired metal binding (measured as ischemia-modified albumin).

Impaired albumin function may be caused by oxidative albumin damage, which has been found in several disease conditions including chronic liver failure. Three fractions of albumin can be discerned according to the redox state of cysteine-34: non-oxidized human mercaptalbumin (HMA) with Cys-34 as free sulfhydryl, reversibly oxidized human nonmercaptalbumin-1 (HNA1) with Cys-34 as mixed disulfide, and irreversibly oxidized human nonmercaptalbumin-2 (HNA2) with Cys-34 oxidized to sulfenic, sulfinic or sulfonic acid. The investigators of this study have previously reported marked oxidative albumin damage in decompensated cirrhosis and even more so in acute-on-chronic liver failure and these alterations were found to be related to prognosis.

Small thiol compounds such as cysteine/cystin or glutathion interacting with the sulfhydryl group at Cys-34 may change the oxidation state of albumin and may be oxidized/reduced themselves. The role of small thiol compounds in various disease conditions and their putative alterations following albumin infusion is currently unknown. Due to the complex logistics of blood sample handling plasma thiol status is measured in a subset of 10 patients only.

While free Cys-34 of albumin accounts for about 80% of the antioxidant capacity of human plasma, both reversible and irreversible oxidation at this site will markedly reduce the antioxidant function of albumin. Besides, irreversibly oxidized albumin causes intense modifications of albumin structure and leads to marked alterations of albumin binding function.

Interestingly, oxidative albumin modification observed in chronic liver failure was paralleled by an impairment of albumin binding capacity as measured by DS binding. This finding among others has led to the concept of effective albumin concentration, which may further aggravate hypoalbuminemia observed in chronic liver failure.

The effect of albumin infusion on oxidative albumin modification and albumin function in chronic liver failure is currently unknown.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Department of Internal Medicine, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Forty consecutive patients receiving albumin infusions routinely in the above-mentioned clinical conditions (paracentesis, hepatorenal syndrome, SBP) will be studied at the Medical University of Graz.

Description

Inclusion Criteria:

  • Age >18 years
  • Routine indication for albumin infusion
  • Informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Albumin infusion
Patients with decompensated cirrhosis and an indication for routine human albumin infusion
Drug: Human albumin
Infusion of human albumin
Other Names:
  • Albumin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Albumin oxidation status
Time Frame: 48 hours
changes in albumin oxidation status (HMA, HNA1, HNA2; percentage) due to albumin infusion measured by HPLC
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
albumin binding capacity for dansylsarcosine
Time Frame: 48 hours
changes in albumin binding capacity (IC50) due to albumin infusion
48 hours
Plasma renin activity
Time Frame: 48 h
changes in plasma renin activity (ELISA; uU/ml) due to albumin infusion
48 h
Plasma copeptin concentration
Time Frame: 48 h
changes in plasma copeptin concentration (ELISA; pmol/l) due to albumin infusion
48 h
Plasma thiol status
Time Frame: 48 h
changes in plasma thiol status (HPLC, umol/l) due to albumin infusion
48 h
serum endotoxin levels
Time Frame: 48 h
changes in serum endotoxin levels (measured by HEK blue LPS detection kit, IU/ml) due to albumin infusion
48 h
Neutrophil phagocytic capacity
Time Frame: 48 h
changes in neutrophil phagocytic capacity (flow cytometry; percentage FITC positive cells) due to albumin infusion
48 h
Neutrophil oxidative burst
Time Frame: 48 h
changes in neutrophil oxidative burst (flow cytometry; percentage FITC positive cells) due to albumin infusion
48 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rudofl E Stauber, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALB-INFUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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