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

University of Pecs

Status and phase: Unknown; Early Phase 1

Conditions: Albumin Therapy; Albumin Supplementation; Sepsis

Treatments: Drug: Human albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03950778

Upecs-UP-MS-ICU-Albumin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Septic patients receiving albumin replacement

Active Comparator group

Description:

Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day

Treatment:

Drug: Human albumin

Septic patients not receiving albumin replacement

No Intervention group