NCT04931225

Brief Summary

The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in Heart Rate (HR) on microcirculatory vascular reactivity vs. usual tachycardia management and evaluate the hemodynamic effects of Landiolol vs. usual management in patients with septic shock.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
2mo left

Started Jul 2022

Typical duration 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 Progress96%
Jul 2022Jul 2026

First Submitted

Initial submission to the registry

May 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

May 14, 2021

Last Update Submit

July 29, 2025

Conditions

Septic Shock

Keywords

Septic shockLandiololMicrocirculatory effectsHeart rateHemodynamic effectsMicrovascular reactivity

Outcome Measures

Primary Outcomes (1)

  • Rate of decrease in heart rate (HR) on microcirculatory vascular reactivity

    The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in HR on microcirculatory vascular reactivity vs. usual tachycardia management in patients with septic shock.

    24 hours

Secondary Outcomes (5)

  • Cardiac flow

    24 hours

  • marbling score

    24 hours

  • skin recoloration time

    24 hours

  • Arterial lactate clearance

    24 hours

  • Measure of Systemic and endothelial inflammation parameters

    24 hours

Study Arms (2)

Landiolol injection

EXPERIMENTAL

Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.

Drug: Landiolol

Usual tachycardia management

NO INTERVENTION

No treatment, usual tachycardia management.

Interventions

LandiololDRUG

Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.

Also known as: Rapibloc
Landiolol injection

Eligibility Criteria

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

You may qualify if:

  • Sinus tachycardia not compensatory, if the doctor considers that the heart rate acceleration should be treated.
  • The study will be carried out in
  • reanimated and stabilized septic shock defined as:
  • Septic shock is tachycardic (HR\>100/min) patients with sepsis (suspected infection + 2 SOFA points) according to the latest international definition and the need to receive noradrenaline to maintain an average blood pressure above 65 mmHg
  • Patient supported for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards and for less than 24 hours to limit confounding factors related to prolonged reanimation (sedation) and empowerment of organ failure in general and vascular in particular. Hemodynamic stabilization will be defined as the absence of increased doses of norepinephrine in the previous two hours to limit the risk of hypotension induced by Landiolol infusion.
  • Age \>18 years
  • Patient (or family member) informed consent signature or emergency consent
  • Affiliation to a social security system

You may not qualify if:

  • Asthma
  • Patients treated with the following bradycardizing drugs:
  • Digitalis
  • Bradycardizing calcium channel blockers
  • Cordarone
  • Other beta-blocker
  • Hypersensitivity to Landiolol or to one of its excipients (Mannitol E421, sodium hydroxide)
  • Sinus disease
  • Cardiogenic shock
  • Decompensated heart failure when considered unrelated to arrhythmia
  • Pregnant or nursing woman,
  • Ward or curative patient
  • Moribund patient
  • Estimated life expectancy less than 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care department, Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

landiolol

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Hafid AIT-OUFELLA, Professor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafid AIT-OUFELLA, Professor

CONTACT

01 49 28 23 15hafid.aitoufella@aphp.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

May 14, 2021

First Posted

June 18, 2021

Study Start

July 18, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

FR(1)