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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Septic Shock, Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years old Sepsis or Septic shock within 24 hours of admission to intensive care with a stable dose of norepinephrine for at least 2 hours to maintain MAP> 65mmHg CRT index> 3 seconds despite the initial resuscitation (administration of antibiotics, volume expansion by crystalloids of 20 mL / Kg, noradrenaline started) between the admission to intensive care and H48 from admission to intensive care Non-opposition of the patient collected by the doctor in charge of the patient between H0 and H6 after admission if the patient is vigilant, otherwise a procedure for collecting non-opposition from relatives will be carried out with collection of the non-opposition of the patient once he is able to give it. Affiliation to a social security regimen (excluding AME) Exclusion Criteria: Patient COVID-19 (+) with respiratory impairment Pregnant and lactating woman Patient under Guardianship / Curatorship Refusal to participate CRT not evaluable (dark or damaged skin) Moribund patient Estimated life expectancy less than 1 month Participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion<br>Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion by measuring the 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. | |
| Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion<br>Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion by measuring the 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT Measure | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock. | 4 hours | 
| mottling score measure | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 4 hours | 
| Diuresis | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 4 hours | 
| Variations in cardiac flow | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 4 hours | 
| Variations in the biological parameters | 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: IL-6, IL-1b, Il-8, TNFa, IL-10 Syndecan-1, heparan sulfat, hyaluronat Circulating microparticles | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial dysfunction, Albumin, Fluid Therapy, Peripheral Tissue Perfusion, Septic shock, Microcirculatory effects, Hemodynamic effects, sepsis