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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients with inclusion criteria already present for more than 36 hours

Patient treated with Dobutamine, adrenaline or isoprenaline

Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)

Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias

Trial design

Design model

Parallel

Treatments tested in this trial

  • echocardiography

    Other intervention

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

  • Landiolol

    Drug

    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.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Variation of mortality rate in landiolol group compared to control group

Time frame
day 28

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

CH Dieppe

Collaborator

CH Elbeuf

Collaborator

CH Le Havre

Collaborator

Centre Hospitalier de Beauvais

Collaborator

CH Compiègne

Collaborator

CH Laon

Collaborator

University Hospital, Caen

Collaborator

CH Cherbourg

Collaborator

University Hospital, Lille

Collaborator

CH Douai

Collaborator

CH Montreuil

Collaborator

Centre Hospitalier de Roubaix

Collaborator

Centre Hospitalier de Bethune

Collaborator

CH Lomme

Collaborator

Centre Hospitalier de Lens

Collaborator

Tourcoing Hospital

Collaborator

Centre Hospitalier VALENCIENNES

Collaborator

Centre Hospitalier Arras

Collaborator

Hospital Ambroise Paré Paris

Collaborator

University Hospital, Brest

Collaborator

Henri Mondor University Hospital

Collaborator

Hospital Avicenne

Collaborator

University Hospital, Montpellier

Collaborator

CH Calais

Collaborator

Hôpital Edouard Herriot

Collaborator

Centre Hospitalier Universitaire de Nīmes

Collaborator

Groupe Hospitalier Pitie-Salpetriere

Collaborator

Hôpital Louis Mourier, Colombes

Collaborator