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New sedation approach may help septic shock patients breathe on their own sooner

NCT ID NCT04710914

Symptom relief Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested whether a gas sedative (isoflurane) could help patients with septic shock wake up and get off a breathing machine faster than standard IV sedation (midazolam). The goal was to reduce complications from long-term sedation and ventilation. Only one patient was enrolled before the study was stopped early, so no firm conclusions can be drawn.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1 person

The number who actually took part.

Started

Dec 2020

Finished

Dec 2020

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: * Major patients, * Sedated with midazolam and sufentanil for a maximum of 3 days and ventilated invasively, * Presenting a duration of sedation and invasive ventilation expected after inclusion between 3 days and 10 days, * Presenting septic shock according to the SEPSIS-3 definition with the following 4 criteria : * Clinical suspicion of infection or positive microbiological sample if applicable, * Organ Failure: SOFA (Sepsis-related Organ Failure Assessment) ≥ 2 (Annex n°5), * Need for vasoactive amines to maintain sufficient organ perfusion pressure, * Arterial lactate \> 2mmol/l, * Stabilized septic shock without the need to increase noradrenaline doses over the last 6 hours, * For women, absence of current pregnancy: negative pregnancy test, * Subjects affiliated to a social security system. * If the patient is unable to sign the consent (emergency situation) the consent will be signed by his or her representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned). In this case, the patient will subsequently be asked for consent to continue the study. Exclusion Criteria: * Refusal of the patient to continue the study after waking up, * Duration of sedation after randomization less than 3 days or more than 10 days.

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Conditions

The condition(s) this trial relates to.

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

  • Rouen University Hospital

    Rouen, 760031, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.