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NCT Number: NCT04748796

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

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.

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Key information

Conditions

Septic Shock Arrhythmias, Cardiac Beta-Blocker Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Infections Inflammation Mortality During Septic Shock Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Antoine VIEILLARD BARON, MD

SUB_INVESTIGATOR

Armand MEKONTSO DESSAP, MD

SUB_INVESTIGATOR

Bernard ALLAOUCHICHE, MD

SUB_INVESTIGATOR

Bertrand SAUNEUF, MD

SUB_INVESTIGATOR

Christophe VINSONNEAU, MD

SUB_INVESTIGATOR

Damien DU CHEYRON, MD

SUB_INVESTIGATOR

David LUIS, MD

SUB_INVESTIGATOR

Didier THEVENIN, MD

SUB_INVESTIGATOR

Eloi GOULLIEUX, MD

SUB_INVESTIGATOR

Fabien LAMBIOTTE, MD

SUB_INVESTIGATOR

Geneviève BARJON, MD

SUB_INVESTIGATOR

Gwenael PRAT, MD

SUB_INVESTIGATOR

Herve Dupont, Pr

SUB_INVESTIGATOR

Jean-Michel CONSTANTIN, MD

SUB_INVESTIGATOR

Joseph BAYEKULA MAFULA, MD

SUB_INVESTIGATOR

Julien Maizel, Pr

CONTACT

[email protected]

(33)3 22 08 78 07

Julien Maizel, Pr

SUB_INVESTIGATOR

Jérôme LEPRETRE, MD

SUB_INVESTIGATOR

Kada KLOUCHE, MD

SUB_INVESTIGATOR

Laurent MULLER, MD

SUB_INVESTIGATOR

MICHOT, MD

SUB_INVESTIGATOR

Maxime GRANIER, MD

SUB_INVESTIGATOR

Mehdi BOUSTA, MD

SUB_INVESTIGATOR

Michel Slama, Pr

CONTACT

[email protected]

(33)3 22 08 78 41

Olivier LEROY, MD

SUB_INVESTIGATOR

Patrick HERBECQ, MD

SUB_INVESTIGATOR

Philippe MOREL, MD

SUB_INVESTIGATOR

Pierre Louis DECLERCQ, MD

SUB_INVESTIGATOR

Saad NSEIR, MD

SUB_INVESTIGATOR

Stephane GAUDRY, MD

SUB_INVESTIGATOR

Thierry VANDERLINDEN, MD

SUB_INVESTIGATOR

UHEL, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria)
  • Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias
  • Patients with any form of cardiac pacing
  • Sick sinus syndrome
  • Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block
  • Known pulmonary hypertension
  • ScVO2 <70%
  • Moribund
  • Cardiac arrest
  • Non-treated phaeochromocytoma
  • Acute asthmatic attack
  • Pregnant or breastfeeding woman
  • Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision),
  • Age <18 years
  • Hypersensitivity to the active substance or to any of the excipients
  • Severe bradycardia (less than 50 beats per minute)
  • Cardiogenic shock
  • Severe hypotension
  • Decompensated heart failure when considered not related to the arrhythmia
  • Severe, uncorrectable metabolic acidosis
  • Presence of significant bleeding, or
  • Acute respiratory distress defined by increased oxygen dependency, polypnea > 30 /min, signs of struggle (pulling, thoraco-abdominal sway) if the patient is not intubated and ventilated.

Treatment and study plan

echocardiography

Other

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.

Primary outcomes

  1. Variation of mortality rate in landiolol group compared to control group

    Time frame: day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Slama Michel, Pr

CONTACT

[email protected]

03 22 08 78 41

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • CH Calais
  • CH Cherbourg
  • CH Dieppe
  • CH Douai
  • CH Elbeuf
  • CH Laon
  • CH Le Havre
  • CH Lomme
  • CH Montreuil
  • Centre Hospitalier Arras
  • Centre Hospitalier Intercommunal de Compiègne-Noyon
  • Centre Hospitalier Universitaire de Nīmes
  • Centre Hospitalier VALENCIENNES
  • Centre Hospitalier de Beauvais
  • Centre Hospitalier de Bethune
  • Centre Hospitalier de Lens
  • Centre Hospitalier de Roubaix
  • Groupe Hospitalier Pitie-Salpetriere
  • Henri Mondor University Hospital
  • Hospital Ambroise Paré Paris
  • Hospital Avicenne
  • Hôpital Edouard Herriot
  • Hôpital Louis Mourier, Colombes
  • Tourcoing Hospital
  • University Hospital, Brest
  • University Hospital, Caen
  • University Hospital, Lille
  • University Hospital, Montpellier

Registry information

Official study title

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

Acronym: HyperBetashock

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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