Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
Recruiting
Phase 3
Interventional Study
Critical Illness Related Corticosteroids Insufficiency
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,092 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 un…
Contacts