NCT03214796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

8 years

First QC Date

June 12, 2017

Last Update Submit

March 3, 2025

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Albumin oxidation status

    changes in albumin oxidation status (HMA, HNA1, HNA2; percentage) due to albumin infusion measured by HPLC

    48 hours

Secondary Outcomes (7)

  • albumin binding capacity for dansylsarcosine

    48 hours

  • Plasma renin activity

    48 h

  • Plasma copeptin concentration

    48 h

  • Plasma thiol status

    48 h

  • serum endotoxin levels

    48 h

  • +2 more secondary outcomes

Study Arms (1)

Albumin infusion

Patients with decompensated cirrhosis and an indication for routine human albumin infusion

Drug: Human albumin

Interventions

Human albuminDRUG

Infusion of human albumin

Also known as: Albumin
Albumin infusion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, neutrophil granulocytes

MeSH Terms

Interventions

Serum Albumin, HumanAlbumins

Intervention Hierarchy (Ancestors)

Serum AlbuminProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Rudofl E Stauber, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

July 12, 2017

Study Start

January 3, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

AU(1)