Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility: an Open Label Prospective Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Several data emphasize the relation between tachycardia (\>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock. Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old

• Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP\<65mmHg or SAP \<90mmHg) requiring vasopressors to maintain MAP\>65mmHg and having a serum lactate level \>2 mmol/L

• Patient who received at least 30ml/kg of fluid and absence of fluid responsiveness

• Left ventricular ejection fraction \>65% (visual or Simpson method using echocardiography)

• Tachycardia \>100 bpm in sinus rhythm with a MAP 65mmHg for more than 1 hour

• Patient receiving invasive mechanical ventilation

• Patients adapted to the ventilator under sedation and analgesia

• Written informed consent

• Patient covered by French national health insurance

Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
Contact Information
Primary
Slama Michel, Pr
slama.michel@chu-amiens.fr
03 22 08 78 41
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 360
Treatments
Experimental: Experimental group
2 days with landiolol IV + usual care
Active_comparator: Control group
usual care according to the attending physician and following the guidelines of surviving sepsis campaign.
Authors
Jean Louis CHAUVET
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Montpellier, University Hospital, Caen, Centre Hospitalier de Bethune, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier Arras, CH Laon, Hospital Ambroise Paré Paris, University Hospital, Brest, Centre Hospitalier de Beauvais, CH Montreuil, CH Elbeuf, CH Calais, CH Le Havre, Hôpital Louis Mourier, Colombes, Hospital Avicenne, Groupe Hospitalier Pitié-Salpêtrière, CH Compiègne, CH Cherbourg, CH Douai, Centre Hospitalier de Roubaix, Tourcoing Hospital, University Hospital, Lille, Henri Mondor University Hospital, CH Dieppe, Centre Hospitalier de Lens, Hôpital Edouard Herriot, Centre Hospitalier VALENCIENNES, CH Lomme
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov