Informations générales (source: ClinicalTrials.gov)
Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial (ADAPT)
Interventional
Phase 3
University Hospital, Limoges (Voir sur ClinicalTrials)
septembre 2020
décembre 2025
05 avril 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) | ||||
| CH DE VERSAILLES SITE ANDRE MIGNOT | hugo BELLUT, MD | Contact (sur clinicalTrials) | |||
| EFS IDF SITE COCHIN | 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 de Nancy - 54511 - Nancy - France | Contact (sur clinicalTrials) | ||||
| CHU Orléans - service de Réanimation - 47067 - Orleans - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg - service de Réanimation - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| CHU Tours - Service de Réanimation - 37044 - Tours - France | Annick LEGRAS, MD | Contact (sur clinicalTrials) | |||
| Limoges University Hospital - 87042 - Limoges - France | Philippe Vignon, MD | Contact (sur clinicalTrials) | |||
| University Hospital - 29200 - Brest - France | Gwanaël PRAT, MD | Contact (sur clinicalTrials) | |||
| University Hospital - 80000 - Amiens - 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 - France | Contact (sur clinicalTrials) | ||||
| Aphp - Ambroise Paré - 75010 - Paris - France | Antoine VIEILLARD-BARON, MD | Contact (sur clinicalTrials) | |||
| Argenteuil Hospital - 95107 - Argenteuil - France | Gaëtan PLANTEFEVE, MD | Contact (sur clinicalTrials) | |||
| CH de Bethune - Béthune - France | Medhi MARZOUCK, MD | Contact (sur clinicalTrials) | |||
| CH de Brive - 19100 - Brive-la-Gaillarde - France | Nicolas PICHON, MD | Contact (sur clinicalTrials) | |||
| CH de Cannes - Cannes - France | Pierre-Marie BERTRAND, MD | Contact (sur clinicalTrials) | |||
| CH de Toulon - 83000 - Toulon - France | Noémie PERES, MD | Contact (sur clinicalTrials) | |||
| CH de Vendée - La Roche-sur-Yon - France | Axel PONTHIEUR, MD | Contact (sur clinicalTrials) | |||
| CH d'Haguenau - 67500 - Haguenau - France | David JOGANAH, MD | Contact (sur clinicalTrials) | |||
| CHU de Grenoble-Alpes - 38043 - La Tronche - France | Pierre-Edouard FLOCH, MD | Contact (sur clinicalTrials) | |||
| Dijon university hospital - 21033 - Dijon - France | Contact (sur clinicalTrials) | ||||
| HCL - Lyon - France | Laurent ARGAUD, MD | Contact (sur clinicalTrials) | |||
| Le Mans Hospital - 72000 - Le Mans - France | CHUDEAU Nicolas, MD | Contact (sur clinicalTrials) | |||
| Lille University Hospital - 59045 - Lille - France | Contact (sur clinicalTrials) | ||||
| Montpellier University Hospital - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Nice University Hospital - 06202 - Nice - France | DOYEN Denis, MD | Contact (sur clinicalTrials) | |||
| Poitiers University Hospital - 86000 - Poitiers - France | Florence BOISSIER, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.