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Arm cuff procedure tested to fight organ failure in septic shock

NCT ID NCT03201575

Disease control Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether a non-invasive arm cuff procedure, called remote ischemic conditioning, could reduce organ failure in 180 adults with septic shock. The cuff was inflated and deflated in cycles to mimic brief blood flow restriction. The goal was to see if this could protect organs from damage caused by the body's response to severe infection.

What this could mean

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

Active substance
Remote ischemic conditioning (arm cuff inflation/deflation cycles)
What this could lead to
If it works, this simple, non-drug technique could help limit organ damage in septic shock, potentially improving survival.
What could go wrong
This is a completed early-stage study with 180 patients. The intervention is experimental and may not show clear benefit; results need confirmation in larger trials.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Nov 2017

Finished

Aug 2019

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 * Hospitalization in an intensive care unit for less than 24 hours * Septic shock evolving for less than 12 hours defined as: * Documented or suspected infection * Norepinephrine administration to maintain a mean arterial pressure ≥ 65 mmHg after volemia correction * Lactatemia \> 2 mmol/L at least once in the past 12 hours before inclusion * Written informed consent signed by the patient or by a next of kin or oral consent given by the patient and as soon as permitted by the clinical state written informed consent signed by the patient. Exclusion Criteria: * Patient who has expressed the wish not to be resuscitated * Contraindication of the use of brachial cuff on both arms * Intercurrent pathology with an expected life expectancy of less than 24 hours * Cardiac arrest * Female patients currently pregnant or women of childbearing age who are not using contraception * Previous inclusion in RECO-Sepsis study * Previous inclusion in another clinical study * Patients without health coverage

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Conditions

The condition(s) this trial relates to.

multiple organ dysfunction syndrome 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

  • CH de Roanne

    Roanne, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU de Grenoble

    Grenoble, France

  • CHU de Montpellier

    Montpellier, France

  • CHU de Saint-Etienne

    Saint-Etienne, France

  • Hôpital Edouard Herriot

    Lyon, France

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