Informations générales (source: ClinicalTrials.gov)
Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial
Interventional
Phase 3
University Hospital, Limoges (Voir sur ClinicalTrials)
septembre 2020
juillet 2025
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Tours - Service de Réanimation - 37044 - Tours 2972191 - Tours - France | Contact (sur clinicalTrials) | ||||
| Poitiers University Hospital - 86000 - Poitiers 2986495 - France | Contact (sur clinicalTrials) | ||||
| University Hospital - 29200 - Brest 3030300 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Angouleme Hospital - 16959 - Angoulême 3037598 - France | Contact (sur clinicalTrials) | ||||
| Aphp - Ambroise Paré - 75010 - Paris 2988507 - France | Contact (sur clinicalTrials) | ||||
| Argenteuil Hospital - 95107 - Argenteuil 3037044 - France | Contact (sur clinicalTrials) | ||||
| CH de Bethune - Béthune 3033002 - France | Contact (sur clinicalTrials) | ||||
| CH de Brive - 19100 - Brive-la-Gaillarde 3029974 - France | Contact (sur clinicalTrials) | ||||
| CH de Cannes - Cannes 3028808 - France | Contact (sur clinicalTrials) | ||||
| CH de Toulon - 83000 - Toulon 2972328 - France | Contact (sur clinicalTrials) | ||||
| CH d'Haguenau - 67500 - Haguenau 3014078 - France | Contact (sur clinicalTrials) | ||||
| CHU Orléans - service de Réanimation - 47067 - Orléans 2989317 - Orleans - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg - service de Réanimation - 67000 - Strasbourg 2973783 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Dijon university hospital - 21033 - Dijon 3021372 - France | Contact (sur clinicalTrials) | ||||
| HCL - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Le Mans Hospital - 72000 - Le Mans 3003603 - France | Contact (sur clinicalTrials) | ||||
| Lille University Hospital - 59045 - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| Limoges University Hospital - 87042 - Limoges 2998286 - France | Contact (sur clinicalTrials) | ||||
| Montpellier University Hospital - 34295 - Montpellier 2992166 - France | Contact (sur clinicalTrials) | ||||
| Nice University Hospital - 06202 - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.