Skip to main content
OpenTrials
Completed

NCT Number: NCT05094856

Effects of Fluid Therapy on Peripheral TIssse 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care department, Hôpital Saint Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. CRT Measure

    Time frame: 4 hours

    Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock.

  2. mottling score measure

    Time frame: 4 hours

    Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.

  3. Diuresis

    Time frame: 4 hours

    Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.

  4. Variations in cardiac flow

    Time frame: 4 hours

    Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.

  5. Variations in the biological parameters

    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:

    • IL-6, IL-1b, Il-8, TNFa, IL-10
    • Syndecan-1, heparan sulfat, hyaluronat
    • Circulating microparticles

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Grifols (funder)
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: REPTILOS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.