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Can a simple protein tame Sepsis's fiery inflammation?

NCT ID NCT03950778

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

40 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • University of Pécs Department of Anaesthesiology and Intensive Therapy

    Pécs, Ifjúság Str 13., 7524, Hungary

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