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

Early Phase 1

• Conditions: Albumin Supplementation; Albumin Therapy; Sepsis
• Interventions: Drug: Human albumin

• Registration Number: NCT03950778
• Lead Sponsor: University of Pecs

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-16
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-13
• Last Update Submitted: 2019-05-13
• Study First Posted: 2019-05-15
• Last Update Posted: 2019-05-15
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The effect of albumin supplementation on PCT level	24 months	The effect of albumin supplementation on the inflammatory and oxidative stress marker PCT will be assesed
The effect of albumin supplementation on CRP level	24 months	The effect of albumin supplementation on the inflammatory and oxidative stress marker CRP will be assesed
The effect of albumin supplementation on serum- total protein concentration	24 months	The effect of albumin supplementation on the inflammatory and oxidative stress markers total protein will be assesed
The effect of albumin supplementation on albumin concentration	24 months	The effect of albumin supplementation on the inflammatory and oxidative stress marker albumin will be assesed

Trial Locations

Locations (2)

Universitty of Pecs Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Pécs, Ifjúság Str.13., Hungary

University of Pécs Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Pécs, Ifjúság Str 13., Hungary