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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Septic Shock; Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT05094856

APHP210918

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

61 participants in 2 patient groups

Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion

Description:

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

Description:

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.