Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial (ADAPT)

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    270
  • sponsor
    University Hospital, Limoges
Updated on 15 October 2022
hypoperfusion
ejection fraction
levosimendan
cardiomyopathy
systolic dysfunction
dobutamine
resuscitation
norepinephrine
shock
septic shock
vasoconstrictors

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.

Details
Condition Sepsis, Cardiomyopathies, Hypoperfusion, Left Ventricular Systolic Dysfunction
Treatment placebos, Dobutamine
Clinical Study IdentifierNCT04166331
SponsorUniversity Hospital, Limoges
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
And lactate > 2 mmol/L
Septic cardiomyopathy: echocardiographically measured LV ejection fraction (EF) ≤ 40%
Informed consent
and LV outflow tract velocity-time integral < 14 cm

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
Acute coronary syndrome
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)
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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