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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Albumin Supplementation; Albumin Therapy
• Intervention / Treatment: Drug: Human albumin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Ifjúság Str 13.
    • Pécs, Ifjúság Str 13., Hungary, 7524
      • University of Pécs Department of Anaesthesiology and Intensive Therapy
  • Ifjúság Str.13.
    • Pécs, Ifjúság Str.13., Hungary, 7624
      • Universitty of Pecs Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Admission to the intensive care unit (ICU) with sepsis or septic shock, or development of sepsis or septic shock during the ICU stay, as defined by the Sepsis-3 criteria
• Serum albumin concentration below 30 g/L
• Written informed consent provided by the participant or the participant's next of kin before enrollment

Exclusion Criteria:

• Age younger than 18 years
• Pregnancy
• Any autoimmune disease
• Refusal or absence of informed consent
• Documented disease or treatment affecting the immune response, including:
• Malignant hematological disease
• Chronic systemic corticosteroid therapy
• Biological therapy
• Immunosuppressive treatment following organ transplantation
• End-stage malignant disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Septic patients receiving albumin replacement; Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day	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.
No Intervention: Septic patients not receiving albumin replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Serum C-Reactive Protein Concentration Through Day 5	Serum C-reactive protein (CRP) concentration was measured in mg/L. Changes over time were compared between the albumin-supplementation and control groups using repeated measurements from each participant.	Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Serum Procalcitonin	The effect of albumin supplementation on the inflammatory marker procalcitonin will be assessed. PCT concentration was measured in ng/mL.	Baseline and daily through Day 5
Change From Baseline in Serum Total Antioxidant Capacity	The effect of albumin supplementation on the oxidative stress markers total antioxidant capacity will be assessed. It was measured as Trolox equivalents in µmol/L.	Baseline, Day 3 and Day 5
Change From Baseline in Serum Albumin	The effect of albumin supplementation on serum albumin level will be assessed. Serum albumin concentration was measured in g/L.	Baseline and daily through Day 5
Change From Baseline in Plasma Reduced Glutathione	The effect of albumin supplementation on the oxidative stress marker plasma reduced glutathione will be assessed. GSH concentration was measured in µmol/L.	Baseline, Day 3 and Day 5
Change From Baseline in Plasma Protein Sulfhydryl Groups	The effect of albumin supplementation on the oxidative stress parameter plasma protein sulfhydryl groups will be assessed. PSH concentration was measured in mol/L.	Baseline, Day 3 and Day 5
Change From Baseline in Plasma Catalase Activity	The effect of albumin supplementation on oxidative stress parameter plasma catalase activity will be assessed. CAT activity was measured in U/mL.	Baseline and through Day 5
Change From Baseline in Plasma Myeloperoxidase Activity	The effect of albumin supplementation on inflammatory marker myeloperoxidase will be assessed. MPO activity was measured in U/L.	Baseline and through Day 5
Change From Baseline in Serum Interleukin-1 Beta	The effect of albumin supplementation on inflammatory marker IL-1 beta will be assessed. IL-1β concentration was measured in pg/mL.	Baseline and through Day 5
Change From Baseline in Serum Interleukin-6	The effect of albumin supplementation on inflammatory marker interleukin-6 will be assessed. IL-6 concentration was measured in pg/mL.	Baseline and through Day 5

Collaborators and Investigators

• Sponsor: University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2023
• Primary Completion (Actual): March 11, 2024
• Study Completion (Actual): April 6, 2024

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Amino Acids, Peptides, and Proteins; Proteins; Blood Proteins; Albumins; Serum Albumin; Serum Albumin, Human
• Other Study ID Numbers: Upecs-UP-MS-ICU-Albumin

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes