NCT04748796

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
15mo left

Started Feb 2021

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Feb 2021Sep 2027

First Submitted

Initial submission to the registry

January 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

6.3 years

First QC Date

January 27, 2021

Last Update Submit

August 19, 2025

Conditions

Septic ShockTachycardiaMortality During Septic ShockBeta-blocker

Keywords

Septic ShockTachycardiamortality during septic shockbeta-blocker

Outcome Measures

Primary Outcomes (1)

  • Variation of mortality rate in landiolol group compared to control group

    day 28

Study Arms (2)

Experimental group

EXPERIMENTAL

2 days with landiolol IV + usual care

Drug: Landiolol

Control group

ACTIVE COMPARATOR

usual care according to the attending physician and following the guidelines of surviving sepsis campaign.

Other: echocardiography

Interventions

echocardiographyOTHER

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

Control group
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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient treated with Dobutamine, adrenaline or isoprenaline
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Shock, SepticTachycardia

Interventions

landiolol

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System Disease

Central Study Contacts

Slama Michel, Pr

CONTACT

03 22 08 78 41slama.michel@chu-amiens.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 10, 2021

Study Start

February 1, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)