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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Hafid AIT-OUFELLA; Phone Number: 01 49 28 23 15; Email: hafid.aitoufella@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Intensive care department, Hôpital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion; 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; 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?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Grifols (funder)
• Investigators: Principal Investigator: Hafid AIT-OUFELLA, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Septic shock; sepsis; Fluid Therapy; Albumin; Microcirculatory effects; Hemodynamic effects; Peripheral Tissue Perfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock
• Other Study ID Numbers: APHP210918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No