Septic ShockPhase 3HyperBetashockNCT04748796
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
A Phase 3 study testing echocardiography and Landiolol in people with Septic Shock and Tachycardia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Tachycardia, Mortality During Septic Shock
- What is being tested?
- echocardiography and Landiolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patients adapted to the ventilator under sedation and analgesia
- Written informed consent
- Patient covered by French national health insurance
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Michel Slama, Pr, (33)3 22 08 78 41, slama.michel@chu-amiens.fr
Julien Maizel, Pr, (33)3 22 08 78 07, maizel.julien@chu-amiens.fr
About this study
Official 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
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
- Being tested
- echocardiography, Landiolol
- Keywords
- Septic Shock, Tachycardia, mortality during septic shock, beta-blocker
- Medical subject headings
- Shock, Septic, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyOther
Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.
LandiololDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 2 days with landiolol IV + usual care Receives: Drug: Landiolol |
| Control group | Active comparator | usual care according to the attending physician and following the guidelines of surviving sepsis campaign. Receives: Other: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of mortality rate in landiolol group compared to control group
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- CH Dieppe, CH Elbeuf, CH Le Havre, Centre Hospitalier de Beauvais, Centre Hospitalier Intercommunal de Compiègne-Noyon, CH Laon, University Hospital, Caen, CH Cherbourg, University Hospital, Lille, CH Douai, CH Montreuil, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, CH Lomme, Centre Hospitalier de Lens, Tourcoing Hospital, Centre Hospitalier VALENCIENNES, Centre Hospitalier Arras, Hospital Ambroise Paré Paris, University Hospital, Brest, Henri Mondor University Hospital, Hospital Avicenne, University Hospital, Montpellier, CH Calais, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Nīmes, Groupe Hospitalier Pitie-Salpetriere, Hôpital Louis Mourier, Colombes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748796
- Sponsor's protocol ID
- PI2020_843_0057
- Acronym
- HyperBetashock
- Status last verified
- Aug 2025
- First submitted
- 27 Jan 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04748796
- Acronym / sponsor ID
- HyperBetashock / PI2020_843_0057
- Conditions
- Septic Shock, Tachycardia, Mortality During Septic Shock, Beta-blocker
- Keywords
- Septic Shock, Tachycardia, mortality during septic shock, beta-blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- CH Dieppe, CH Elbeuf, CH Le Havre, Centre Hospitalier de Beauvais, Centre Hospitalier Intercommunal de Compiègne-Noyon, CH Laon, University Hospital, Caen, CH Cherbourg, University Hospital, Lille, CH Douai, CH Montreuil, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, CH Lomme, Centre Hospitalier de Lens, Tourcoing Hospital, Centre Hospitalier VALENCIENNES, Centre Hospitalier Arras, Hospital Ambroise Paré Paris, University Hospital, Brest, Henri Mondor University Hospital, Hospital Avicenne, University Hospital, Montpellier, CH Calais, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Nīmes, Groupe Hospitalier Pitie-Salpetriere, Hôpital Louis Mourier, Colombes
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Landiolol2 days with landiolol IV + usual care |
| Control group | Active comparator | Other: echocardiographyusual care according to the attending physician and following the guidelines of surviving sepsis campaign. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyFull echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12. | Other | Control group |
| LandiololPatients 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. | Drug | Experimental group |
Primary outcome
Variation of mortality rate in landiolol group compared to control group
Time frame: day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing echocardiography and Landiolol in people with Septic Shock and Tachycardia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Slama Michel, Pr (03 22 08 78 41, slama.michel@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of mortality rate in landiolol group compared to control group (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.