Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1092 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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 ≥ 4 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).

Conditions

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Critical Illness Related Corticosteroids Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

For CIRCI patients: hydrocortisone + fludrocortisone therapy.

Group Type EXPERIMENTAL

Investigational products administration

Intervention Type DRUG

Investigational products include:

* Hydrocortisone hemisuccinate 50 mg: one intravenous injection every 6 hours, and
* 9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.

All treatments will be stopped after 7 days or until the patient has left the intensive care unit (whichever occurs first) without tapering off.

Placebo

For CIRCI patients: hydrocortisone placebo + fludrocortisone placebo

Group Type PLACEBO_COMPARATOR

Placebo administration

Intervention Type DRUG

Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.

Interventions

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Investigational products administration

Investigational products include:

* Hydrocortisone hemisuccinate 50 mg: one intravenous injection every 6 hours, and
* 9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.

All treatments will be stopped after 7 days or until the patient has left the intensive care unit (whichever occurs first) without tapering off.

Intervention Type DRUG

Placebo administration

Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult (≥ 18 years);
* Hospitalized in an intensive care unit;
* SOFA score ≥ 4, for at least 6 consecutive hours;
* Informed written consent from patient or from legally authorized next of kin, or emergency deferred consent;
* Affiliation to a social security system or to a universal health coverage (Couverture Maladie Universelle, CMU).

Exclusion Criteria

* Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol \< 5 μg/dL or peak (60) cortisol \<18 μg/dL)
* Expected death or withdrawal of life-sustaining treatments within 48 hours
* Known chronic adrenal insufficiency
* Concomitant treatment that inhibits cortisol production
* Septic shock (Singer Jama 2016)
* Active tuberculosis or fungal infection
* Active viral hepatitis or active infection with herpes viruses
* Hypersensitivity or contraindication to hydrocortisone, fludrocortisone or Synacthène® or any of their excipients ( SmPC)
* Patient needing either anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason (Such as those suffering from COVID-19 pneumonia requiring oxygen therapy).
* Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days
* Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
* Pregnant or breastfeeding woman
* Moribund patient
* Previously enrolled in this study
* Participation to another interventional study that focuses on CIRCI and/or corticoid drugs and/or that addresses a similar primary endpoint as Hornbill ( ventilator- and vasopressor-free survival )
* Patient under guardianship or tutorship

Note: Included patients for whom acute adrenal insufficiency would be detected in the Synacthen ® test performed as part of the research for the diagnosis of CIRCI will not be randomized since they should be treated by corticosteroids.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No