Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency (HORNbILL)

  • STATUS
    Recruiting
  • End date
    Feb 21, 2026
  • participants needed
    1092
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 21 March 2022

Summary

The study aims at assessing the efficacy and the safety of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.

Description

The hypothalamic-pituitary-adrenal axis together with the noradrenergic/vasopressinergic system are the main systems of host response to stress. In 2008 the scientific community described a syndrome called critical illness related corticosteroids insufficiency (CIRCI) in which body homeostasis is lost owing to insufficient cortisol production or bioactivity in tissues. Recent updates of international guidelines have spelled out the pathophysiology, diagnosis and management of CIRCI. The prevalence of CIRCI varies according to case mix and severity of illness. The combination of hydrocortisone and fludrocortisone improved outcomes in septic shock, a condition often complicated with CIRCI. However, there is insufficient evidence on the efficacy of corticosteroids in patients with CIRCI and without septic shock. The hypothesis of the study is that the hydrocortisone-fludrocortisone association will improve ventilation and vasopressor free survival in ICU patients with Critical illness related Corticosteroid Insufficiency.

Patients with a SOFA score ≥ 6 will be screened for CIRCI. Patients suffering from CIRCI will be randomized to receive hydrocortisone and fludrocortisone or their placebo. Patients without CIRCI will receive standard of care and will be followed up during 90 days (cohort-observational study).

Details
Condition Critical Illness Related Corticosteroids Insufficiency
Treatment Placebo Administration, Investigational products administration
Clinical Study IdentifierNCT04404400
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥ 18 years
Hospitalized in an intensive care unit
SOFA score ≥ 6, for at least 6 consecutive hours
Informed written consent from patient or from legally authorized next of kin, or emergency deferred consent

Exclusion Criteria

Septic shock
Active tuberculosis or fungal infection
Active viral hepatitis or active infection with herpes viruses
Hypersensitivity to corticosteroids
Patient requiring corticosteroids
Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days
Pregnant or breastfeeding woman
Moribund patient
Persons without social security
Under guardianship
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