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Blood filtering procedure tested as new weapon against deadly sepsis

NCT ID NCT04057872

Disease control Sponsor: Alberta Health Services, Calgary 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested the safety of a blood-filtering procedure called therapeutic plasma exchange in 17 adults with septic shock, a life-threatening infection that causes organ failure. The procedure removes the liquid part of the blood and replaces it with fluids or donor plasma. The goal was to see if it could be done safely in this setting, with future studies needed to check if it actually helps patients recover.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
therapeutic plasma exchange (a procedure that removes and replaces blood plasma with fluids, albumin, or plasma)
What this could lead to
If this procedure proves safe and effective in larger studies, it could offer a new way to reduce organ failure and death from severe sepsis.
What could go wrong
This is a very small, early-phase safety study with only 17 participants. It is not designed to prove the treatment works, and side effects or lack of benefit are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Oct 2020

Finished

Dec 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 Adult patients (age ≥18) with a documented or strong clinical suspicion of infection that meets the definition of septic shock as per the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Exhibiting two of the four clinical signs of inflammation: 1. Core temperature \> 38oC or \< 36oC 2. Heart rate \> 90 beats per minute 3. Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation 4. White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils We will further identify the subset with a hospital mortality in excess of 40%: 1. \>30 mls/kg fluid resuscitation 2. Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE 3. Lactate \>2 mmol/l. Exclusion Criteria Patients will be excluded in cases where death is deemed inevitable or imminent during admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment.

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome

As listed by the trial registrant

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

Septic shock

Contacts and locations

Locations

  • Peter Lougheed Centre

    Calgary, Alberta, T3M 1M4, Canada

  • South Health Campus

    Calgary, Alberta, T3M 1M4, Canada

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