Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility

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.

Conditions

• Septic Shock
• Tachycardia
• Mortality During Septic Shock
• Beta-blocker

Interventions

OTHER

echocardiography

Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.

DRUG

Landiolol

Patients randomized to the experimental group will be treated according to the standard of care plus for 2 days with landiolol IV started at a dose of 1 microgram/kg/min and progressively increased every 10 minutes to a maximum of 40 micrograms/kg/min.

Sponsors & Collaborators

• CH Dieppe

  collaborator UNKNOWN

• CH Elbeuf

  collaborator UNKNOWN

• CH Le Havre

  collaborator UNKNOWN

• Centre Hospitalier de Beauvais

  collaborator OTHER

• CH Compiègne

  collaborator UNKNOWN

• CH Laon

  collaborator UNKNOWN

• University Hospital, Caen

  collaborator OTHER

• CH Cherbourg

  collaborator UNKNOWN

• University Hospital, Lille

  collaborator OTHER

• CH Douai

  collaborator UNKNOWN

• CH Montreuil

  collaborator UNKNOWN

• Centre Hospitalier de Roubaix

  collaborator OTHER

• Centre Hospitalier de Bethune

  collaborator NETWORK

• CH Lomme

  collaborator UNKNOWN

• Centre Hospitalier de Lens

  collaborator OTHER

• Tourcoing Hospital

  collaborator OTHER

• Centre Hospitalier VALENCIENNES

  collaborator OTHER

• Centre Hospitalier Arras

  collaborator OTHER

• Hospital Ambroise Paré Paris

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hospital Avicenne

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• CH Calais

  collaborator UNKNOWN

• Hôpital Edouard Herriot

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Groupe Hospitalier Pitié-Salpêtrière

  collaborator UNKNOWN

• Hôpital Louis Mourier, Colombes

  collaborator UNKNOWN

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2027-06-30

Completion

2027-09-30

Countries

• France

Study Locations