Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04020263
Status:
RECRUITING
Last Update Posted:
2019-07-18
First Post:
2019-06-28
Brief Title:
Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
NOT_YET_RECRUITING
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:
LevoHeartShock
Brief Summary:
Cardiogenic shock CS mortality remains high 40 Despite their frequent use few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS Based on experts opinions the combination of norepinephrine-dobutamine is generally recommended as a first line strategy Inotropic agents increase myocardial contractility thereby increasing cardiac output Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure It may represent an ideal agent in cardiogenic shock since it improves myocardial contractility without increasing cAMP or calcium concentration At present there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock Our hypothesis is that the early use of levosimendan by enabling the discontinuation of dobutamine would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None