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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septic patients receiving albumin replacement | Active Comparator | Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day |
|
| Septic patients not receiving albumin replacement | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human albumin | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Csaba Csontos, PhD | Contact | 003672536000 /32428 | csaba.csontos@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pécs Department of Anaesthesiology and Intensive Therapy | Recruiting | Pécs | Ifjúság Str 13. | 7524 | Hungary |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Universitty of Pecs Department of Anaesthesiology and Intensive Therapy | Recruiting | Pécs | Ifjúság Str.13. | 7624 | Hungary |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |