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Adjunctive DobutAmine in sePtic cardiomyopathy with Tissue hypoperfusion: a randomized controlled multi-center trial
EU CTIS ID: 2024-517839-50-00
What this study is testing
To assess the effects of adjunctive Dobutamine infusion versus placebo on organs failure in fluid-filled septic shock patients stabilized under vasopressor support with echocardiographically documented septic cardiomyopathy
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years hospitalized in ICU
- Septic shock (Sepsis-3 definition) on ICU admission or during ICU stay: 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 within the 24h preceding randomization
- Septic cardiomyopathy: echocardiographically measured or visually assessed LV ejection fraction (EF) ≤ 40% and LV outflow tract velocity-time integral < 14±1.5 cm (or RV outflow tract velocity-time integral according to image quality) not related to persistent hypovolemia
- Informed consent
You likely can't join if
- Pregnancy or breast feeding
- Absence of affiliation to Social Security
- Subjects under juridical protection.
- Hypersensitivity to Dobutamine, 5% Dextrose, or to the exipients
- Ventricular rate >150 bpm if sinus rhythm, or > 130 bpm if non-sinus rhythm
- Severe ventricular arrhythmia
See the full eligibility criteria
- Age ≥ 18 years hospitalized in ICU
- Septic shock (Sepsis-3 definition) on ICU admission or during ICU stay: 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 within the 24h preceding randomization
- Septic cardiomyopathy: echocardiographically measured or visually assessed LV ejection fraction (EF) ≤ 40% and LV outflow tract velocity-time integral < 14±1.5 cm (or RV outflow tract velocity-time integral according to image quality) not related to persistent hypovolemia
- Informed consent
- Pregnancy or breast feeding
- Absence of affiliation to Social Security
- Subjects under juridical protection.
- Hypersensitivity to Dobutamine, 5% Dextrose, or to the exipients
- Ventricular rate >150 bpm if sinus rhythm, or > 130 bpm if non-sinus rhythm
- 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)
- Ongoing acute coronary syndrome
- Indication for or insertion of any extracorporeal life support
- Decision to limit care or moribund status (life expectancy < 24 h) not related to the severity of septic cardiomyopathy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.