Albumin SupplementationEarly Phase 1NCT03950778
The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients
A Early Phase 1 study testing Human albumin in people with Albumin Supplementation and Albumin Therapy, run by University of Pecs at 2 sites in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Albumin Supplementation, Albumin Therapy, Sepsis
- What is being tested?
- Human albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesHungary
- Study dates
- 4 Mar 2023to 6 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Admission to the intensive care unit (ICU) with sepsis or septic shock, or development of sepsis or septic shock during the ICU stay, as defined by the Sepsis-3 criteria
- Serum albumin concentration below 30 g/L
- Written informed consent provided by the participant or the participant's next of kin before enrollment
Who cannot join
- Age younger than 18 years
- Pregnancy
- Any autoimmune disease
- Refusal or absence of informed consent
- Documented disease or treatment affecting the immune response, including:
- Malignant hematological disease
Show all 10Show fewer
- Chronic systemic corticosteroid therapy
- Biological therapy
- Immunosuppressive treatment following organ transplantation
- End-stage malignant disease
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
University of Pécs Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjúság Str 13., 7524
Universitty of Pecs Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjúság Str.13., 7624
About this study
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.
Read the 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.
- Conditions
- Albumin Supplementation, Albumin Therapy, Sepsis
- Being tested
- Human albumin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
Participants were randomly assigned to one of two groups using sealed-envelope randomization. Participants in the intervention group received 20% human albumin solution for three consecutive days, up to a maximum daily dose of 3 × 100 mL, with a target serum albumin concentration of 30 g/L. Participants in the control group did not receive albumin while their serum albumin concentration remained above 15 g/L. If it fell below 15 g/L, rescue albumin was administered according to standard clinical practice, and the participant was excluded from the final study analysis.
Blood samples were collected immediately after admission to the intensive care unit and at approximately the same time on each subsequent study day. Urine was collected over consecutive 24-hour periods. Changes in the measured parameters were evaluated over the five-day observation period.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients receiving albumin replacement | Active comparator | Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day Receives: Drug: Human albumin |
| Septic patients not receiving albumin replacement | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum C-Reactive Protein Concentration Through Day 5
Serum C-reactive protein (CRP) concentration was measured in mg/L. Changes over time were compared between the albumin-supplementation and control groups using repeated measurements from each participant.
Measured: Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 5
Secondary outcomes (9)
Change From Baseline in Serum Procalcitonin
The effect of albumin supplementation on the inflammatory marker procalcitonin will be assessed. PCT concentration was measured in ng/mL.
Measured: Baseline and daily through Day 5
Change From Baseline in Serum Total Antioxidant Capacity
The effect of albumin supplementation on the oxidative stress markers total antioxidant capacity will be assessed. It was measured as Trolox equivalents in µmol/L.
Measured: Baseline, Day 3 and Day 5
Change From Baseline in Serum Albumin
The effect of albumin supplementation on serum albumin level will be assessed. Serum albumin concentration was measured in g/L.
Measured: Baseline and daily through Day 5
Change From Baseline in Plasma Reduced Glutathione
The effect of albumin supplementation on the oxidative stress marker plasma reduced glutathione will be assessed. GSH concentration was measured in µmol/L.
Measured: Baseline, Day 3 and Day 5
Change From Baseline in Plasma Protein Sulfhydryl Groups
The effect of albumin supplementation on the oxidative stress parameter plasma protein sulfhydryl groups will be assessed. PSH concentration was measured in mol/L.
Measured: Baseline, Day 3 and Day 5
Change From Baseline in Plasma Catalase Activity
The effect of albumin supplementation on oxidative stress parameter plasma catalase activity will be assessed. CAT activity was measured in U/mL.
Measured: Baseline and through Day 5
Change From Baseline in Plasma Myeloperoxidase Activity
The effect of albumin supplementation on inflammatory marker myeloperoxidase will be assessed. MPO activity was measured in U/L.
Measured: Baseline and through Day 5
Change From Baseline in Serum Interleukin-1 Beta
The effect of albumin supplementation on inflammatory marker IL-1 beta will be assessed. IL-1β concentration was measured in pg/mL.
Measured: Baseline and through Day 5
Change From Baseline in Serum Interleukin-6
The effect of albumin supplementation on inflammatory marker interleukin-6 will be assessed. IL-6 concentration was measured in pg/mL.
Measured: Baseline and through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start4 Mar 2023
- Primary completion11 Mar 2024
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Albumin SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950778
- Sponsor's protocol ID
- Upecs-UP-MS-ICU-Albumin
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2019
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients
- ClinicalTrials.gov ID
- NCT03950778
- Acronym / sponsor ID
- Upecs-UP-MS-ICU-Albumin
- Conditions
- Albumin Supplementation, Albumin Therapy, Sepsis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic patients receiving albumin replacement | Active comparator | Drug: Human albuminSeptic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day |
| Septic patients not receiving albumin replacement | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Admission to the intensive care unit (ICU) with sepsis or septic shock, or development of sepsis or septic shock during the ICU stay, as defined by the Sepsis-3 criteria
- Serum albumin concentration below 30 g/L
- Written informed consent provided by the participant or the participant's next of kin before enrollment
Key exclusion criteria (10 listed)
- Age younger than 18 years
- Pregnancy
- Any autoimmune disease
- Refusal or absence of informed consent
- Documented disease or treatment affecting the immune response, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human albuminParticipants were randomly assigned to one of two groups using sealed-envelope randomization. Participants in the intervention group received 20% human albumin solution for three consecutive days, up to a maximum daily dose of 3 × 100 mL, with a target serum albumin concentration of 30 g/L. Participants in the control group did not receive albumin while their serum albumin concentration remained above 15 g/L. If it fell below 15 g/L, rescue albumin was administered according to standard clinical practice, and the participant was excluded from the final study analysis. Blood samples were collected immediately after admission to the intensive care unit and at approximately the same time on each subsequent study day. Urine was collected over consecutive 24-hour periods. Changes in the measured parameters were evaluated over the five-day observation period. | Drug | Septic patients receiving albumin replacement |
Primary outcome
Change From Baseline in Serum C-Reactive Protein Concentration Through Day 5
Time frame: Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 5
Serum C-reactive protein (CRP) concentration was measured in mg/L. Changes over time were compared between the albumin-supplementation and control groups using repeated measurements from each participant.
9 secondary outcomes
Change From Baseline in Serum Procalcitonin
Time frame: Baseline and daily through Day 5
Change From Baseline in Serum Total Antioxidant Capacity
Time frame: Baseline, Day 3 and Day 5
Change From Baseline in Serum Albumin
Time frame: Baseline and daily through Day 5
Change From Baseline in Plasma Reduced Glutathione
Time frame: Baseline, Day 3 and Day 5
Change From Baseline in Plasma Protein Sulfhydryl Groups
Time frame: Baseline, Day 3 and Day 5
Change From Baseline in Plasma Catalase Activity
Time frame: Baseline and through Day 5
Change From Baseline in Plasma Myeloperoxidase Activity
Time frame: Baseline and through Day 5
Change From Baseline in Serum Interleukin-1 Beta
Time frame: Baseline and through Day 5
Change From Baseline in Serum Interleukin-6
Time frame: Baseline and through Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Albumin Supplementation
Active, not recruiting
Egg Albumin and Agave Fructans With Exercise in Hemodialysis
Sarcopenia, Chronic Kidney Disease
RecruitingPhase 4
Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
Liver Transplantation, Acute Kidney Injury
RecruitingPhase 2
LGG Supplementation in Patients With AUD and ALD
Alcohol Use Disorder, Alcohol-associated Liver Disease
Active, not recruiting
I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis
Pulmonary Tuberculosis, Hypoalbuminemia
Not yet recruiting
Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.
Stroke, Hypoalbuminemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human albumin in people with Albumin Supplementation and Albumin Therapy, run by University of Pecs at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Serum C-Reactive Protein Concentration Through Day 5 (time frame: Baseline at ICU admission (Day 1) and once daily on Days 2, 3, 4, and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.