Can a simple protein tame Sepsis's fiery inflammation?
NCT ID NCT03950778
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial asks whether giving extra albumin—a key protein in the blood—can lower inflammation and oxidative stress in people with sepsis, a severe infection that can cause organ failure. Adults in intensive care with sepsis and low albumin levels are randomly assigned to receive either albumin infusions for three days or standard care. Researchers will track changes in inflammatory markers like C-reactive protein and procalcitonin, as well as antioxidant capacity, to see if albumin supplementation offers a protective effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Human albumin solution (20%) given intravenously for three days
- What this could lead to
- If albumin helps, it could point toward a simple supportive therapy to ease inflammation and oxidative stress in sepsis patients in intensive care.
- What could go wrong
- This is a very early, small trial, so results may not be conclusive. Albumin is generally safe, but any IV therapy carries risks like allergic reactions or fluid overload.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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40 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Apr 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Chronic systemic corticosteroid therapy * Biological therapy * Immunosuppressive treatment following organ transplantation * End-stage malignant disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Universitty of Pecs Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjúság Str.13., 7624, Hungary
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University of Pécs Department of Anaesthesiology and Intensive Therapy
Pécs, Ifjúság Str 13., 7524, Hungary
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a computer model speed up sepsis blood tests?