Using Dobutamine to treat septic cardiomyopathy with low blood flow

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

This study tests if using Dobutamine can help improve heart function and blood flow in patients with septic cardiomyopathy who are in critical condition.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Limoges (other)
• Locations: 27 sites (Amiens and 26 other locations)
• Trial ID: NCT04166331 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Dobutamine as an adjunctive treatment for patients suffering from septic cardiomyopathy characterized by tissue hypoperfusion. The study aims to optimize therapeutic management in septic shock patients by improving left ventricular function and enhancing oxygen delivery to tissues. Patients will be monitored in intensive care units and assessed using echocardiography to evaluate their cardiac function and response to treatment. The trial compares the effects of Dobutamine against a placebo in this critical patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who are hospitalized in the ICU with septic shock and echocardiographically confirmed left ventricular systolic dysfunction.

Not a fit: Patients who are pregnant, breastfeeding, or have severe ventricular arrhythmias or hypersensitivity to Dobutamine will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with septic cardiomyopathy by enhancing heart function and reducing organ dysfunction.

How similar studies have performed: While the use of Dobutamine in septic cardiomyopathy has been suggested, this specific approach is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Amiens and 26 other locations

• University Hospital — Amiens, France (WITHDRAWN)
• Angouleme Hospital — Angoulême, France (TERMINATED)
• Argenteuil Hospital — Argenteuil, France (RECRUITING)
• University Hospital — Brest, France (RECRUITING)
• CH de Brive — Brive-la-Gaillarde, France (RECRUITING)
• CH de Bethune — Béthune, France (RECRUITING)
• CH de Cannes — Cannes, France (RECRUITING)
• Aphp - Henri Mondor — Créteil, France (TERMINATED)
• Dijon university hospital — Dijon, France (TERMINATED)
• CH d'Haguenau — Haguenau, France (RECRUITING)
• CH de Vendée — La Roche-sur-Yon, France (RECRUITING)
• CHU de Grenoble-Alpes — La Tronche, France (RECRUITING)
• CH de Versailles — Le Chesnay, France (RECRUITING)
• Le Mans Hospital — Le Mans, France (RECRUITING)
• Lille University Hospital — Lille, France (TERMINATED)
• Limoges University Hospital — Limoges, France (RECRUITING)
• HCL — Lyon, France (RECRUITING)
• Montpellier University Hospital — Montpellier, France (TERMINATED)
• CHU de Nancy — Nancy, France (WITHDRAWN)
• Nice University Hospital — Nice, France (RECRUITING)
• CHU Orléans - service de Réanimation — Orleans, France (TERMINATED)
• Aphp - Ambroise Paré — Paris, France (RECRUITING)
• Hôpital Cochin - service de Réanimation — Paris, France (WITHDRAWN)
• Poitiers University Hospital — Poitiers, France (RECRUITING)
• CHU Strasbourg - service de Réanimation — Strasbourg, France (TERMINATED)
• CH de Toulon — Toulon, France (RECRUITING)
• CHU Tours - Service de Réanimation — Tours, France (RECRUITING)

Study contacts

• Principal investigator: VIGNON Philippe, MD — University Hospital, Limoges
• Study coordinator: VIGNON Philippe, MD

Conditions: Sepsis, Cardiomyopathies, Hypoperfusion, Left Ventricular Systolic Dysfunction, sepsis