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Can a blood protein boost survival in septic shock?

NCT ID NCT07212582

Disease control Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving extra human albumin—a natural blood protein—along with standard care can help people survive septic shock after surgery. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. The trial will enroll 304 adults in the surgical ICU, giving some patients albumin infusions for up to 3 days to keep their albumin levels high. The main goal is to see if more patients are alive at 28 days.

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 (20% solution)
What this could lead to
If it works, this could point toward a simple, widely available treatment to improve survival in surgical septic shock.
What could go wrong
This is a single-center trial with 304 patients, so results may not apply everywhere. Previous studies on albumin in sepsis have had mixed results, so there is no guarantee of benefit.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

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: * Adult patients (≥18 years) admitted to the surgical intensive care unit (SICU). * Diagnosis or suspicion of surgical infection requiring surgery or surgical intervention within 48 hours of ICU admission. * Septic shock, defined as: * Mean arterial pressure \<65 mmHg after adequate fluid resuscitation or requirement for vasopressors to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour, and * Evidence of organ dysfunction (Sequential Organ Failure Assessment (SOFA) score increase ≥2) or signs of tissue hypoperfusion (serum lactate \>2 mmol/L, oliguria \<0.5 mL/kg/h \>2 h, or clinical evidence of poor peripheral perfusion). Exclusion Criteria: * Refusal of consent or do-not-resuscitate (DNR) status. * More than 24 hours since meeting inclusion criteria. * Contraindication to albumin infusion or history of severe allergic reaction to albumin. * Conditions where albumin infusion is already indicated (e.g., large-volume paracentesis \>5 L, hepatorenal syndrome, spontaneous bacterial peritonitis, plasmapheresis, cirrhosis, nephrotic syndrome, protein-losing enteropathy, severe burns, post-cardiac or thoracic surgery). * Evidence of fluid overload or pulmonary edema (bilateral crepitations, chest infiltrates consistent with pulmonary edema, Central Venous Pressure \>15 mmHg, Pulmonary Artery Occlusion Pressure \[PAOP\] \>18 mmHg, or N-terminal pro-B-type Natriuretic Peptide \[NT-proBNP\] \>900 pg/mL) * End-stage renal disease or receiving chronic renal replacement therapy. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Critical Illness toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Medicine, Siriraj Hospital, Mahidol University

    Bangkok, Bangkoknoi, 10700, Thailand

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