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Can a protein fluid help septic shock patients? small study tests the waters

NCT ID NCT05208242

Knowledge-focused Sponsor: Manchester University NHS Foundation Trust 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving a concentrated protein fluid called albumin, along with standard fluids, is possible in patients with septic shock (a life-threatening infection causing very low blood pressure). 47 adults took part to see if doctors could recruit enough patients for a future larger trial. The main goal was to check feasibility, not to prove if albumin works better.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

47 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

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: 1. Suspected or documented infection 2. Organ dysfunction defined as SOFA score ≥2 3. Need for vasopressor infusion for ≥2 hours 4. Serum lactate ≥2 mmol/L 5. Eligible for critical care admission without any restrictions Exclusion Criteria: 1. \>24 hours since the time point of meeting all inclusion criteria 2. \<18 years of age 3. Pregnancy 4. Patients with a known allergy to albumin 5. Jehova's witnesses or other patients expressing a known objection to the use of blood products 6. Previous receipt of human albumin solution for the episode of sepsis in question 7. Previous enrolment in this study

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

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

Sepsis Septic shock Shock, toxic

Contacts and locations

Locations

  • Manchester Royal Infirmary

    Manchester, Lancashire, M13 9WL, United Kingdom

  • Wythenshawe Hospital

    Manchester, Lancashire, M23 9LT, United Kingdom

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