Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04931225
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2021-05-14
Brief Title:
LANdiolol MIcrocirculatory Effects During Septic chOc MILANOS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
LANdiolol MIcrocirculatory Effects During Septic chOc
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MILANOS
Brief Summary:
The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection from 05 to 10 µgkgmin 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
Detailed Description:
This is a Phase 3 prospective randomized open label evaluation of the efficacy of continuous intravenous Landiolol injection up to a 15 decrease in HR on microcirculatory vascular reactivity vs usual tachycardia management
Design
A monocentric open-label randomised superiority clinical trial
Sample size
44 patients 22 in each group
Treatments groups
Continuous intravenous Landiolol injection from 05 to 10 µgkgmin during 12 hours up to a 15 decrease in HR on microcirculatory vascular reactivity vs usual tachycardia management
Treatment duration
24 hours
Assessement
Landiolol Rapiblocs perfusion will be started at T0 at 05 mcgkgmin and increased by 05 mcgkgmin every 30 minutes in order to achieve a 15 T1 decrease in HR within the limit of 10 mcgkgmin Then the dosage will be maintained for 2 hours T2 then the drug will be stopped gradually over 2 hours
Maximum duration of Landiolol infusion will be 12 hours
No interim analysis is planned Analysis will be performed at the end of the study after data review and freezing of database
Design
A monocentric open-label randomised superiority clinical trial
Sample size
44 patients 22 in each group
Treatments groups
Continuous intravenous Landiolol injection from 05 to 10 µgkgmin during 12 hours up to a 15 decrease in HR on microcirculatory vascular reactivity vs usual tachycardia management
Treatment duration
24 hours
Assessement
Landiolol Rapiblocs perfusion will be started at T0 at 05 mcgkgmin and increased by 05 mcgkgmin every 30 minutes in order to achieve a 15 T1 decrease in HR within the limit of 10 mcgkgmin Then the dosage will be maintained for 2 hours T2 then the drug will be stopped gradually over 2 hours
Maximum duration of Landiolol infusion will be 12 hours
No interim analysis is planned Analysis will be performed at the end of the study after data review and freezing of database
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None