Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion
Status:
Recruiting
Trial end date:
2022-09-26
Target enrollment:
Participant gender:
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. 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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Limoges
Collaborators:
Centre d'Investigation Clinique 1415 Centre d’Investigation Clinique 1415