NCT05094856

Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock

Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Sepsis

Timeline

• Start date: 2022-02-23
• Primary completion: 2023-02-16
• Completion: 2023-03-16
• First posted: 2021-10-26
• Last updated: 2024-06-07

Locations

1 site across 1 country: France