Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-27 @ 6:07 AM
Study NCT ID:
NCT05325957
Status:
WITHDRAWN
Last Update Posted:
2024-08-16
First Post:
2022-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock in Angers University Hospital
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock in Angers University Hospital
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Canadian study completed before beginning of French study sites
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOVECAR-A
Brief Summary:
the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.
Detailed Description:
An interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. This last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group.
The strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. This is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered.
However, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.
The strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. This is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered.
However, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.
Study Oversight
Has Oversight DMC:
True
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?: