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Can a heart drug save organs in sepsis? new trial aims to find out

NCT ID NCT04166331

Disease control Sponsor: University Hospital, Limoges 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This completed Phase 3 trial tested whether dobutamine, a heart-strengthening drug, can reduce organ failure in 136 ICU patients with septic cardiomyopathy and low blood flow. Patients received either dobutamine or a placebo alongside standard care. The study measured changes in organ function over three days to see if the drug helps improve outcomes.

What this could mean

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

Active substance
Dobutamine
What this could lead to
If successful, this could provide a proven treatment to improve organ function in septic shock patients with heart problems.
What could go wrong
This is a completed Phase 3 trial, but previous similar drugs have failed or caused side effects. The benefit may be small or not apply to all patients.

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

136 people

The number who actually took part.

Started

Sep 2020

Finished

Jul 2025

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 hospitalized in ICU * \> Septic shock (Sepsis-3 definition): 1. Clinically suspected or documented acute infection 2. Responsible for organ dysfunction(s): change in SOFA ≥ 2 points 3. With persisting hypotension (systolic and/or mean arterial pressure \< 90 / \< 65 mmHg) despite adequate fluid resuscitation (≥ 30 mL/kg, unless presence of pulmonary venous congestion) 4. Requiring vasopressor support (Norepinephrine) to maintain steady mean arterial pressure ≥ 65 mmHg 5. And lactate \> 2 mmol/L * Septic cardiomyopathy: echocardiographically measured LV ejection fraction (EF) ≤ 40% and LV outflow tract velocity-time integral \< 14 cm * Informed consent Exclusion Criteria: * Pregnancy or breast feeding * Hypersensitivity to Dobutamine, 5% Dextrose, or to the excipients * Ventricular rate \> 130 bpm (sinus rhythm or not) * Severe ventricular arrhythmia * Obstructive cardiomyopathy with pressure gradient at rest ≥ 50 mmHg unrelated to uncorrected hypovolemia * Severe aortic stenosis: mean gradient \> 40 mmHg, peak aortic jet velocity \> 4 m/s, aortic valve area \< 1 cm² (aortic valve area index \< 0.6 cm²/m²) * Acute coronary syndrome * Decision to limit care or moribund status (life expectancy \< 24 h) * Absence of affiliation to Social Security * Subjects under juridical protection.

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Conditions

The condition(s) this trial relates to.

bacterial myocarditis cardiomyopathy infectious disease with sepsis left ventricular failure Sepsis Ventricular Dysfunction, Left

As listed by the trial registrant

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

Cardiomyopathies Hypoperfusion Left ventricular systolic dysfunction Sepsis

Contacts and locations

Locations

  • Angouleme Hospital

    Angoulême, 16959, France

  • Aphp - Ambroise Paré

    Paris, 75010, France

  • Aphp - Henri Mondor

    Créteil, 94010, France

  • Argenteuil Hospital

    Argenteuil, 95107, France

  • CH d'Haguenau

    Haguenau, 67500, France

  • CH de Bethune

    Béthune, France

  • CH de Brive

    Brive-la-Gaillarde, 19100, France

  • CH de Cannes

    Cannes, France

  • CH de Toulon

    Toulon, 83000, France

  • CHU Orléans - service de Réanimation

    Orléans, Orleans, 47067, France

  • CHU Strasbourg - service de Réanimation

    Strasbourg, Strasbourg, 67000, France

  • CHU Tours - Service de Réanimation

    Tours, Tours, 37044, France

  • Dijon university hospital

    Dijon, 21033, France

  • HCL

    Lyon, France

  • Le Mans Hospital

    Le Mans, 72000, France

  • Lille University Hospital

    Lille, 59045, France

  • Limoges University Hospital

    Limoges, 87042, France

  • Montpellier University Hospital

    Montpellier, 34295, France

  • Nice University Hospital

    Nice, 06202, France

  • Poitiers University Hospital

    Poitiers, 86000, France

  • University Hospital

    Brest, 29200, France

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