Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT05094856
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2021-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
Status:
COMPLETED
Status Verified Date:
2024-06
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:
REPTILOS
Brief Summary:
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
Detailed Description:
This is a transversal study allowing to compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion
Design:
• A multicentric, open-label, transversal study
Sample size :
60 patients
Assessement:
Between the admission to intensive care and 48 hours after admission, the patient will be included after collection of the non-opposition form.
The patient will receive volume expansion either by 0.9% saline (500mL) or by 20% albumin (100mL) over 15 minutes.
Repeated clinical measurements will be performed at H0, H0.5 and H1 (respectively at 0, 30 and 60 minutes).
A blood sample will be taken just before the volume expansion and 4 hours after, at the same time as the samples usually taken as part of the treatment.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.
Design:
• A multicentric, open-label, transversal study
Sample size :
60 patients
Assessement:
Between the admission to intensive care and 48 hours after admission, the patient will be included after collection of the non-opposition form.
The patient will receive volume expansion either by 0.9% saline (500mL) or by 20% albumin (100mL) over 15 minutes.
Repeated clinical measurements will be performed at H0, H0.5 and H1 (respectively at 0, 30 and 60 minutes).
A blood sample will be taken just before the volume expansion and 4 hours after, at the same time as the samples usually taken as part of the treatment.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.
Study Oversight
Has Oversight DMC:
False
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?: