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

NCT03950778 | Unknown Early Phase 1 DMC

• 1 other identifier: Upecs-UP-MS-ICU-Albumin
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Albumin Supplementation; Albumin Therapy; Sepsis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Septic patients receiving albumin replacement

ACTIVE COMPARATOR

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

Drug: Human albumin

Septic patients not receiving albumin replacement

NO INTERVENTION

Interventions

Human albumin DRUG

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.

Septic patients receiving albumin replacement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (2)

University of Pécs Department of Anaesthesiology and Intensive Therapy

Pécs, Ifjúság Str 13., 7524, Hungary

RECRUITING

Universitty of Pecs Department of Anaesthesiology and Intensive Therapy

Pécs, Ifjúság Str.13., 7624, Hungary

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Central Study Contacts

Csaba Csontos, PhD

CONTACT

003672536000 /32428; csaba.csontos@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 15, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

HU (2)