Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04280497

Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-10-01

1800

Participants Needed

1

Research Sites

294 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

I

Institut National de la Santé Et de la Recherche Médicale, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity. Secondary objectives and endpoints: * Mortality and health-related quality of life at 6 months; * Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90); * Daily secondary infections (up to 90 days) * Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day) * Daily gastroduodenal bleeding (up to 28 day) * Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).

CONDITIONS

Official Title

Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years old or older
  • Admitted to ICU with proven or suspected infection as the main diagnosis
  • Diagnosis of community-acquired pneumonia related sepsis, vasopressor dependency, septic shock, or acute respiratory distress syndrome (ARDS) with specified clinical criteria
  • Tested for one or more specific biomarkers including CIRCI, Endocan, GILZ, DUSP-1, MDW, lymphopenia, Transcriptomic SRS2, Endotype B, PCR COVID-19, PCR Influenza, other respiratory viruses, or glucocorticoid response
  • Signed informed and written consent or assent from representative when applicable
  • Affiliated to a social security system or universal health coverage
  • Under guardianship or curatorship included
  • Included in case of simple emergency legal definition
  • Managed with COVID-19 and have biological samples available
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Expected death or withdrawal of life-sustaining treatments within 48 hours
  • Previously enrolled in this study
  • Formal indication for corticosteroids according to most recent international guidelines
  • Vaccination with live virus within past 6 months
  • Hypersensitivity to hydrocortisone, fludrocortisone, betamethasone dipropionate, or their excipients
  • Women of childbearing potential not using contraception
  • Nursing women (cream application restrictions for infected or ulcerated areas)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP

Garches, Hauts-de-Seine, France, 92380

Actively Recruiting

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Research Team

D

Djillali ANNANE, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

12

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