Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion

Launched by UNIVERSITY HOSPITAL, LIMOGES · Nov 15, 2019

Keywords

ClinConnect Summary

The ADAPT trial is studying whether a medication called Dobutamine can help improve blood flow and reduce organ problems in patients who have septic shock and septic cardiomyopathy. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure and organ dysfunction. The trial aims to find out if giving Dobutamine can enhance oxygen delivery to tissues, which may lead to better recovery for patients suffering from these conditions.

To be eligible for this trial, participants must be over 18 years old, hospitalized in the Intensive Care Unit (ICU) with septic shock, and show signs of heart dysfunction, specifically a left ventricular ejection fraction (a measure of how well the heart pumps) of 40% or less. Patients who are pregnant, have certain heart conditions, or are in critical health situations may not qualify. Those who do participate will be closely monitored and may receive either Dobutamine or a placebo (a non-active substance) to compare the effects on their condition. This trial is currently recruiting, and it's an important step in understanding how to better treat severe cases of septic shock.

Gender

ALL

Eligibility criteria

• 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
• 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.