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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Albumin Supplementation, Albumin Therapy, Sepsis

Intervention / Treatment
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* Drug: Human albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primarily, patients with sepsis or septic shock are enrolled into patients who are admitted to an intensive care class or who become septic in the intensive care unit (based on the sepsis definition). Exclusion Criteria: Under 18 years old documented treatment or co-morbidity affecting the immune response: malignant hematological disease chronic steroid use, biological therapy, taking immunosuppressive drugs after organ transplantation, end stage tumor disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Septic patients receiving albumin replacement<br>Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day | Drug: Human albumin<br>* Patients are divided into 2 groups by envelope randomization. In the treated group, albumin supplementation occurs up to a target of 30 g / l at the end of the test period at a maximum dose of 3 x 100 ml, and no albumin is added above the control value of 20 g / l. Patients with albumin below 20 g / l in the control group are excluded from the study and albumin supplemented. Blood samples are taken directly at the intensive care class, and at the same time on the following days. Urine was collected for 24 hours. The kinetics of the parameters are examined for five days.<br>|
| No Intervention: Septic patients not receiving albumin replacement<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of albumin supplementation on PCT level | The effect of albumin supplementation on the inflammatory and oxidative stress marker PCT will be assesed | 24 months | 
| The effect of albumin supplementation on CRP level | The effect of albumin supplementation on the inflammatory and oxidative stress marker CRP will be assesed | 24 months | 
| The effect of albumin supplementation on serum- total protein concentration | The effect of albumin supplementation on the inflammatory and oxidative stress markers total protein will be assesed | 24 months | 
| The effect of albumin supplementation on albumin concentration | The effect of albumin supplementation on the inflammatory and oxidative stress marker albumin will be assesed | 24 months |