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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950778
• Other study ID #: Upecs-UP-MS-ICU-Albumin
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2019
• Source: University of Pecs
• Contact: Csaba Csontos, PhD
• Phone: 003672536000 /32428
• Email: csaba.csontos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Albumin Supplementation
• Albumin Therapy
• Sepsis

Intervention

Drug:
• Human albumin
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.

Locations

Country	Name	City	State
Hungary	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.

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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