SepsisPhase 3ADAPTNCT04166331
Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion
A Phase 3 study testing Dobutamine in people with Sepsis and Cardiomyopathies, run by University Hospital, Limoges at 21 sites in France.
Trial summary
Sepsis induces both a systolic and diastolic cardiac dysfunction. The prevalence of this septic cardiomyopathy ranges between 30 and 60% according to the timing of assessment and definition used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Cardiomyopathies, Hypoperfusion
- What is being tested?
- Dobutamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 21 sitesFrance
- Study dates
- 20 Sep 2020to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years hospitalized in ICU
- > Septic shock (Sepsis-3 definition):
- Clinically suspected or documented acute infection
- Responsible for organ dysfunction(s): change in SOFA ≥ 2 points
- 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)
- Requiring vasopressor support (Norepinephrine) to maintain steady mean arterial pressure ≥ 65 mmHg
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Acute coronary syndrome
- Decision to limit care or moribund status (life expectancy < 24 h)
- Absence of affiliation to Social Security
- Subjects under juridical protection.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Angouleme Hospital
Angoulême, 16959
Argenteuil Hospital
Argenteuil, 95107
CH de Bethune
Béthune
University Hospital
Brest, 29200
CH de Brive
Brive-la-Gaillarde, 19100
CH de Cannes
Cannes
Aphp - Henri Mondor
Créteil, 94010
Dijon university hospital
Dijon, 21033
CH d'Haguenau
Haguenau, 67500
Le Mans Hospital
Le Mans, 72000
Lille University Hospital
Lille, 59045
Limoges University Hospital
Limoges, 87042
HCL
Lyon
Montpellier University Hospital
Montpellier, 34295
Nice University Hospital
Nice, 06202
CHU Orléans - service de Réanimation
Orléans, Orleans, 47067
Aphp - Ambroise Paré
Paris, 75010
Poitiers University Hospital
Poitiers, 86000
CHU Strasbourg - service de Réanimation
Strasbourg, Strasbourg, 67000
CH de Toulon
Toulon, 83000
CHU Tours - Service de Réanimation
Tours, Tours, 37044
About this study
Official title: Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial
Sepsis induces both a systolic and diastolic cardiac dysfunction. The prevalence of this septic cardiomyopathy ranges between 30 and 60% according to the timing of assessment and definition used. Although the prognostic role of septic cardiomyopathy remains debated, sepsis-induced left ventricular (LV) systolic dysfunction may be severe and associated with tissue hypoperfusion, while it appears to fully recover in survivors. Accordingly, optimization of therapeutic management of septic cardiomyopathy may contribute to improve tissue hypoperfusion in increasing oxygen delivery, and to reduce related organ dysfunctions in septic shock patients.
Echocardiography is currently the recommended first-line modality to assess patients with acute circulatory failure.
Read more
Current Surviving Sepsis Campaign strongly recommends Norepinephrine as the first-choice vasopressor in fluid-filled patients with septic shock. In contrast, the use of Dobutamine is only suggested (weak recommendation, low quality of evidence) in patients with persistent tissue hypoperfusion despite adequate fluid resuscitation and vasopressor support. Levosimendan, an alternative inodilator, has failed preventing acute organ dysfunction in septic patients and has induced more supraventricular tachyarrhythmias than in the control group. Data supporting Dobutamine in this setting are scarce and primarily physiologic and based on monitored effects of this drug on hemodynamics and indices of tissue perfusion.
No randomized controlled trials have yet compared the effects of Dobutamine versus placebo on clinical outcomes. In open-labelled, small sample trials, the ability of septic patients to increase their oxygen delivery during Dobutamine administration appears to be associated with lower mortality.
The tested hypothesis in the ADAPT trial is that Dobutamine will reduce tissue hypoperfusion and associated organ dysfunctions in patients with septic shock and associated septic cardiomyopathy. In doing so, it may participate in improving clinical outcomes.
- Being tested
- Placebos, Dobutamine
- Keywords
- sepsis, Cardiomyopathies, Hypoperfusion, Left Ventricular Systolic Dysfunction
- Medical subject headings
- Sepsis, Cardiomyopathies, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
Placebo will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min. Dose adaptation will be left at the discretion of attending physician.
DobutamineDrug
Dobutamine will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min. Dose adaptation will be left at the discretion of attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min Receives: Drug: Placebos |
| Experimental | Experimental | Dobutamine will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequential Organ Failure Assessment (SOFA) score evolution
Evolution of a modified Sequential (Sepsis-Related) Organ Failure Assessment (SOFA) score (no gradation of the neurologic system) between baseline (before randomization) and Day 1, Day 2 and Day 3 after randomization. Min value =0. Max value =20 . The highest score means the worst situation
Measured: Day 0 to Day 3
Secondary outcomes (33)
Circulating lactate level measurement
Biological indices of tissue dysoxia at baseline, hour 6, Day1, Day 2 and Day 3 after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Central venous oxygen saturation (ScvO2) measurement
Biological indices of tissue dysoxia at baseline, hour 6, Day1, Day 2 and Day 3 after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Open-labelled Dobutamine dayly maximal dose used as rescue therapy
Requirement of organ function supports during ICU stay. Maximal dose in mcg/kg/min of open-labelled Dobutamine used as rescue therapy
Measured: through study completion, an average 90 days
Open-labelled Dobutamine duration used as rescue therapy
Requirement of organ function supports during ICU stay. Duration in days of open-labelled Dobutamine used as rescue therapy
Measured: through study completion, an average of 90 days
Vasopressor support duration
Requirement of organ function supports during ICU stay. Duration in days of vasopressor support
Measured: through study completion, an average of 90 days
Vasopressor support dayly maximal dose
Requirement of organ function supports during ICU stay. Maximal dose in mg/h by day of vasopressor support
Measured: through study completion, an average of 90 days
Invasive mechanical ventilation duration
Requirement of organ function supports during ICU stay. Duration of invasive mechanical ventilation
Measured: through study completion, an average of 90 days
Renal replacement therapy number
Requirement of organ function supports during ICU stay. Number of session of renal replacement therapy (excluding hemodialysis patient for chronic renal failure at the time of randomization)
Measured: through study completion, an average of 90 days
Renal replacement therapy duration
Requirement of organ function supports during ICU stay. Duration of renal replacement therapy (excluding hemodialysis patient for chronic renal failure at the time of randomization)
Measured: through study completion, an average of 90 days
Arterial pressure measurement
Systolic, diastolic and mean arterial blood pressure (in mmHg) at Baseline, h6, Day 1, Day 2 and Day3after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
heart rate measurement
Heart rate measurement in bpm at Baseline, Hour 6, Day 1, Day 2 and Day3 after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Central venous pressure measurement
Central venous pressure in cm H2O at Baseline, Hour 6, Day 1, Day 2 and Day3 after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Cardiac index measurement
Cardiac index measurement in L/min/m2 at Baseline, Hour 6, Day 1, Day 2 and Day3 after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Stroke volume measurement
Stroke volume measurement in mL status at Baseline, Hour 6, Day 1, Day 2 and Day3 after initiating Dobutamine / placebo
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Hypotension measurement
Severe cardiovascular adverse events from inform consent to ICU discharge : Hypotension related to worsened vasoplegia
Measured: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Supraventricular arrhythmias measurement
Severe cardiovascular adverse events from inform consent to ICU discharge. Supraventricular arrhythmias with ventricular rate > 140 bpm
Measured: through study completion, an average of 90 days
Ventricular arrhythmias measurement
Severe cardiovascular adverse events from inform consent to ICU discharge. Ventricular arrhythmias
Measured: through study completion, an average of 90 days
Occurence of Acute coronary syndrome
Severe cardiovascular adverse events from inform consent to ICU discharge. Acute coronary syndrome
Measured: through study completion, an average of 90 days
Occurence of Stroke
Severe cardiovascular adverse events during ICU stay. Stroke
Measured: through study completion, an average of 90 days
Mortality
Number of death
Measured: Day 90
Mortality causes
Cause of death
Measured: Day 90
Organ function free supports
Number of days free from vasopressor support, invasive mechanical ventilation, renal replacement therapy from inform consent to ICU discharge
Measured: Day 90
Number of days in ICU and hospital
Length of ICU and hospital stay
Measured: Day 90
echocardiographic assessment of left ventricular systolic function
ejection fraction measurement
Measured: Day 0 and Day 1
Leucocyte subsets level
Leucocyte subsets level according to the severity of the sepsis-induced LV systolic dysfunction and hemodynamic effects of the study drug administration
Measured: Hour 6
Cytokines level
tumor necrosis factor (TNF) -α, Interferon ɣ, Interleukin-6, 8 and 10 cytokines concentration will be assess according to the severity of the sepsis-induced LV systolic dysfunction and hemodynamic effects of the study drug administration. Result for each cytokine concentration will be given in picograms per milliliter.
Measured: Hour 6
LV global longitudinal strain measurement
LV segmental deformation longitudinal analysis
Measured: Hour 6, Day 1, Day 2 AND Day 3
RV free wall strain measurement
deformation of right ventricular myocardial tissue / routinely using with echocardiography or post exam analysis
Measured: Hour 6, Day 1, Day 2 AND Day 3
LV volume measurement
Ratio between systolic and diastolic left ventricular volume / routinely using with echocardiography
Measured: Hour 6, Day 1, Day 2 AND Day 3
LV ejection fraction measurement
Cardiac output measurement with echocardiography Doppler (in centers routinely using transpulmonary thermodilution). Quality of left ventricular contraction
Measured: Hour 6, Day 1, Day 2 AND Day 3
RV volume measurement
Ratio between systolic and diastolic right ventricular volume / routinely using with echocardiography
Measured: Hour 6, Day 1, Day 2 AND Day 3
RV ejection fraction measurement
Cardiac output measurement with echocardiography Doppler (in centers routinely using transpulmonary thermodilution). Quality of right ventricular contraction
Measured: Hour 6, Day 1, Day 2 AND Day 3
Transpulmonary thermodilution measurement
In selected centers routinely using continuous monitoring of cardiac output using transpulmonary thermodilution: agreement of cardiac output measurement with echocardiography Doppler.
Measured: Hour 6, Day 1, Day 2 AND Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start20 Sep 2020
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Centre d'Investigation Clinique 1415
- Responsible party
- Sponsor
- Investigators
- VIGNON Philippe, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166331
- Sponsor's protocol ID
- 87RI18_0012 (ADAPT)
- Acronym
- ADAPT
- Status last verified
- Nov 2025
- First submitted
- 25 Oct 2019
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vignon P, Leger J, Evrard B, Goudelin M, Vaidie J, Brit S, Giraudeau B. Adjunctive dobutamine in patients with septic cardiomyopathy and tissue hypoperfusion: a blinded randomised controlled multicentre trial study protocol of the ADAPT-dobutamine trial. BMJ Open. 2025 Jun 30;15(6):e101200. doi: 10.1136/bmjopen-2025-101200.
PubMed 40588393
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial
- ClinicalTrials.gov ID
- NCT04166331
- Acronym / sponsor ID
- ADAPT / 87RI18_0012 (ADAPT)
- Keywords
- sepsis, Cardiomyopathies, Hypoperfusion, Left Ventricular Systolic Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Centre d'Investigation Clinique 1415
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis induces both a systolic and diastolic cardiac dysfunction. The prevalence of this septic cardiomyopathy ranges between 30 and 60% according to the timing of assessment and definition used. Although the prognostic role of septic cardiomyopathy remains debated, sepsis-induced left ventricular (LV) systolic dysfunction may be severe and associated with tissue hypoperfusion, while it appears to fully recover in survivors. Accordingly, optimization of therapeutic management of septic cardiomyopathy may contribute to improve tissue hypoperfusion in increasing oxygen delivery, and to reduce related organ dysfunctions in septic shock patients.
Echocardiography is currently the recommended first-line modality to assess patients with acute circulatory failure.
Current Surviving Sepsis Campaign strongly recommends Norepinephrine as the first-choice vasopressor in fluid-filled patients with septic shock. In contrast, the use of Dobutamine is only suggested (weak recommendation, low quality of evidence) in patients with persistent tissue hypoperfusion despite adequate fluid resuscitation and vasopressor support. Levosimendan, an alternative inodilator, has failed preventing acute organ dysfunction in septic patients and has induced more supraventricular tachyarrhythmias than in the control group. Data supporting Dobutamine in this setting are scarce and primarily physiologic and based on monitored effects of this drug on hemodynamics and indices of tissue perfusion.
No randomized controlled trials have yet compared the effects of Dobutamine versus placebo on clinical outcomes. In open-labelled, small sample trials, the ability of septic patients to increase their oxygen delivery during Dobutamine administration appears to be associated with lower mortality.
The tested hypothesis in the ADAPT trial is that Dobutamine will reduce tissue hypoperfusion and associated organ dysfunctions in patients with septic shock and associated septic cardiomyopathy. In doing so, it may participate in improving clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlacebosPlacebo will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min |
| Experimental | Experimental | Drug: DobutamineDobutamine will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years hospitalized in ICU
- > Septic shock (Sepsis-3 definition):
- Septic cardiomyopathy: echocardiographically measured LV ejection fraction (EF) ≤ 40% and LV outflow tract velocity-time integral < 14 cm
- Informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebosPlacebo will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min. Dose adaptation will be left at the discretion of attending physician. | Drug | Control |
| DobutamineDobutamine will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min. Dose adaptation will be left at the discretion of attending physician. | Drug | Experimental |
Primary outcome
Sequential Organ Failure Assessment (SOFA) score evolution
Time frame: Day 0 to Day 3
Evolution of a modified Sequential (Sepsis-Related) Organ Failure Assessment (SOFA) score (no gradation of the neurologic system) between baseline (before randomization) and Day 1, Day 2 and Day 3 after randomization. Min value =0. Max value =20 . The highest score means the worst situation
33 secondary outcomes
Circulating lactate level measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Central venous oxygen saturation (ScvO2) measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Open-labelled Dobutamine dayly maximal dose used as rescue therapy
Time frame: through study completion, an average 90 days
Open-labelled Dobutamine duration used as rescue therapy
Time frame: through study completion, an average of 90 days
Vasopressor support duration
Time frame: through study completion, an average of 90 days
Vasopressor support dayly maximal dose
Time frame: through study completion, an average of 90 days
Invasive mechanical ventilation duration
Time frame: through study completion, an average of 90 days
Renal replacement therapy number
Time frame: through study completion, an average of 90 days
Renal replacement therapy duration
Time frame: through study completion, an average of 90 days
Arterial pressure measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
heart rate measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Central venous pressure measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Cardiac index measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Stroke volume measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Hypotension measurement
Time frame: Hour 0, Hour 6, Day 1, Day 2 and Day 3
Supraventricular arrhythmias measurement
Time frame: through study completion, an average of 90 days
Ventricular arrhythmias measurement
Time frame: through study completion, an average of 90 days
Occurence of Acute coronary syndrome
Time frame: through study completion, an average of 90 days
Occurence of Stroke
Time frame: through study completion, an average of 90 days
Mortality
Time frame: Day 90
Mortality causes
Time frame: Day 90
Organ function free supports
Time frame: Day 90
Number of days in ICU and hospital
Time frame: Day 90
echocardiographic assessment of left ventricular systolic function
Time frame: Day 0 and Day 1
Leucocyte subsets level
Time frame: Hour 6
Cytokines level
Time frame: Hour 6
LV global longitudinal strain measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
RV free wall strain measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
LV volume measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
LV ejection fraction measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
RV volume measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
RV ejection fraction measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
Transpulmonary thermodilution measurement
Time frame: Hour 6, Day 1, Day 2 AND Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 40588393Vignon P, Leger J, Evrard B, Goudelin M, Vaidie J, Brit S, Giraudeau B. Adjunctive dobutamine in patients with septic cardiomyopathy and tissue hypoperfusion: a blinded randomised controlled multicentre trial study protocol of the ADAPT-dobutamine trial. BMJ Open. 2025 Jun 30;15(6):e101200. doi: 10.1136/bmjopen-2025-101200.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VIGNON Philippe, MD principal investigator
University Hospital, Limoges
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dobutamine in people with Sepsis and Cardiomyopathies, run by University Hospital, Limoges at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequential Organ Failure Assessment (SOFA) score evolution (time frame: Day 0 to Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.