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The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients

NCT03950778 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-17

No results posted yet for this study

Summary

There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients.

The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon.

Conditions

  • Albumin Supplementation
  • Albumin Therapy
  • Sepsis

Interventions

DRUG

Human albumin

Participants were randomly assigned to one of two groups using sealed-envelope randomization. Participants in the intervention group received 20% human albumin solution for three consecutive days, up to a maximum daily dose of 3 × 100 mL, with a target serum albumin concentration of 30 g/L. Participants in the control group did not receive albumin while their serum albumin concentration remained above 15 g/L. If it fell below 15 g/L, rescue albumin was administered according to standard clinical practice, and the participant was excluded from the final study analysis. Blood samples were collected immediately after admission to the intensive care unit and at approximately the same time on each subsequent study day. Urine was collected over consecutive 24-hour periods. Changes in the measured parameters were evaluated over the five-day observation period.

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-04
Primary Completion
2024-03-11
Completion
2024-04-06

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03950778 on ClinicalTrials.gov