Intensive care department, Hôpital Saint Antoine
Paris, 75012, France
NCT Number: NCT05094856
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
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Notify Me18 year and older
All sexes
Observational
Paris, 75012, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 hour
Proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.
Time frame: 4 hours
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock.
Time frame: 4 hours
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.
Time frame: 4 hours
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.
Time frame: 4 hours
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.
Time frame: 4 hours
Variations in the biological parameters between H0 and H4 will be analyzed from 5 ml of blood taken in addition, in accordance with the usual practice, in a sepsis/septic shock:
Assistance Publique - Hôpitaux de Paris
Other
Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
Acronym: REPTILOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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