Clinical trial NCT05094856: Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock
Official title: Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Sepsis
Keywords: Endothelial dysfunction
Albumin
Fluid Therapy
Peripheral Tissue Perfusion
Septic shock
Microcirculatory effects
Hemodynamic effects
sepsis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Grifols (funder)
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-10-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis/septic shock hospitalized in intensive care with signs of peripheral hypoperfusion persisting despite the initial resuscitation.

Septic shock corresponds to patients with sepsis (infection + 2 SOFA points according to the latest international definition and the need to administer noradrenaline to maintain mean arterial pressure\> 65 mmHg.

In total, patients with reanimated and hemodynamically stabilized sepsis/septic shock will be included. The diagnostic and therapeutic management will comply in all points with the usual service protocol and international recommendations.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 hour
Secondary outcomes:
measure: CRT Measure
timeFrame: 4 hours
measure: mottling score measure
timeFrame: 4 hours
measure: Diuresis
timeFrame: 4 hours
measure: Variations in cardiac flow
timeFrame: 4 hours
measure: Variations in the biological parameters
timeFrame: 4 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Intensive care department, Hôpital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hafid AIT-OUFELLA
role: PRINCIPAL_INVESTIGATOR
References: