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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
University of Pécs Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjúság Str 13., Hungary
Universitty of Pecs Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjúság Str.13., Hungary
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.
Time frame: Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 5
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and through Day 5
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