Clinical trial NCT03950778: The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients
Official title: The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Albumin Supplementation
Albumin Therapy
Sepsis
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of albumin supplementation on PCT level
timeFrame: 24 months
measure: The effect of albumin supplementation on CRP level
timeFrame: 24 months
measure: The effect of albumin supplementation on serum- total protein concentration
timeFrame: 24 months
measure: The effect of albumin supplementation on albumin concentration
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs Department of Anaesthesiology and Intensive Therapy
state: Ifjúság Str 13.
city: Pécs
country: Hungary
facility: Universitty of Pecs Department of Anaesthesiology and Intensive Therapy
state: Ifjúság Str.13.
Study officials:
References: