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NCT Number: NCT03950778

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.

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Key information

Conditions

Albumin Supplementation Albumin Therapy Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pécs Department of Anaesthesiology and Intensive Therapy, Pécs, Ifjúság Str 13., Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human albumin

Drug

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.

Primary outcomes

  1. Change From Baseline in Serum C-Reactive Protein Concentration Through Day 5

    Time frame: Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 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.

Secondary outcomes

  1. Change From Baseline in Serum Procalcitonin

    Time frame: Baseline and daily through Day 5

    The effect of albumin supplementation on the inflammatory marker procalcitonin will be assessed. PCT concentration was measured in ng/mL.

  2. Change From Baseline in Serum Total Antioxidant Capacity

    Time frame: Baseline, Day 3 and Day 5

    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.

  3. Change From Baseline in Serum Albumin

    Time frame: Baseline and daily through Day 5

    The effect of albumin supplementation on serum albumin level will be assessed. Serum albumin concentration was measured in g/L.

  4. Change From Baseline in Plasma Reduced Glutathione

    Time frame: Baseline, Day 3 and Day 5

    The effect of albumin supplementation on the oxidative stress marker plasma reduced glutathione will be assessed. GSH concentration was measured in µmol/L.

  5. Change From Baseline in Plasma Protein Sulfhydryl Groups

    Time frame: Baseline, Day 3 and Day 5

    The effect of albumin supplementation on the oxidative stress parameter plasma protein sulfhydryl groups will be assessed. PSH concentration was measured in mol/L.

  6. Change From Baseline in Plasma Catalase Activity

    Time frame: Baseline and through Day 5

    The effect of albumin supplementation on oxidative stress parameter plasma catalase activity will be assessed. CAT activity was measured in U/mL.

  7. Change From Baseline in Plasma Myeloperoxidase Activity

    Time frame: Baseline and through Day 5

    The effect of albumin supplementation on inflammatory marker myeloperoxidase will be assessed. MPO activity was measured in U/L.

  8. Change From Baseline in Serum Interleukin-1 Beta

    Time frame: Baseline and through Day 5

    The effect of albumin supplementation on inflammatory marker IL-1 beta will be assessed. IL-1β concentration was measured in pg/mL.

  9. Change From Baseline in Serum Interleukin-6

    Time frame: Baseline and through Day 5

    The effect of albumin supplementation on inflammatory marker interleukin-6 will be assessed. IL-6 concentration was measured in pg/mL.

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 15, 2019
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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