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

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 Overview

• Status: Unknown
• Conditions: Sepsis; Albumin Supplementation; Albumin Therapy
• Intervention / Treatment: Drug: Human albumin

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Ifjúság Str 13.
    • Pécs, Ifjúság Str 13., Hungary, 7524
      • Recruiting
      • University of Pécs Department of Anaesthesiology and Intensive Therapy
      • Contact: Csaba Csontos, PhD; Phone Number: 003672536000/ 32428
  • Ifjúság Str.13.
    • Pécs, Ifjúság Str.13., Hungary, 7624
      • Recruiting
      • Universitty of Pecs Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Septic patients receiving albumin replacement; Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day	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.
No Intervention: Septic patients not receiving albumin replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Upecs-UP-MS-ICU-Albumin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes