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

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04748796
Acronym
HyperBetashock
Enrollment
360
Registered
2021-02-10
Start date
2021-02-01
Completion date
2027-09-30
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Septic Shock, Tachycardia, mortality during septic shock, beta-blocker

Brief 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.

Interventions

OTHERechocardiography

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

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

CH Dieppe
CollaboratorUNKNOWN
CH Elbeuf
CollaboratorUNKNOWN
CH Le Havre
CollaboratorUNKNOWN
Centre Hospitalier de Beauvais
CollaboratorOTHER
CH Compiègne
CollaboratorUNKNOWN
CH Laon
CollaboratorUNKNOWN
University Hospital, Caen
CollaboratorOTHER
CH Cherbourg
CollaboratorUNKNOWN
University Hospital, Lille
CollaboratorOTHER
CH Douai
CollaboratorUNKNOWN
CH Montreuil
CollaboratorUNKNOWN
Centre Hospitalier de Roubaix
CollaboratorOTHER
Centre Hospitalier de Bethune
CollaboratorNETWORK
CH Lomme
CollaboratorUNKNOWN
Centre Hospitalier de Lens
CollaboratorOTHER
Tourcoing Hospital
CollaboratorOTHER
Centre Hospitalier VALENCIENNES
CollaboratorOTHER
Centre Hospitalier Arras
CollaboratorOTHER
Hospital Ambroise Paré Paris
CollaboratorOTHER
University Hospital, Brest
CollaboratorOTHER
Henri Mondor University Hospital
CollaboratorOTHER
Hospital Avicenne
CollaboratorOTHER
University Hospital, Montpellier
CollaboratorOTHER
CH Calais
CollaboratorUNKNOWN
Hôpital Edouard Herriot
CollaboratorOTHER
Centre Hospitalier Universitaire de Nīmes
CollaboratorOTHER
Groupe Hospitalier Pitié-Salpêtrière
CollaboratorUNKNOWN
Hôpital Louis Mourier, Colombes
CollaboratorUNKNOWN
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Variation of mortality rate in landiolol group compared to control groupday 28

Countries

France

Contacts

Primary ContactSlama Michel, Pr
slama.michel@chu-amiens.fr03 22 08 78 41

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026