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Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

NCT04404400 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1092

Last updated 2025-04-27

No results posted yet for this study

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.

Conditions

  • Critical Illness Related Corticosteroids Insufficiency

Interventions

DRUG

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.

DRUG

Placebo administration

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nicholas HEMING, MD, PhD · General Intensive care Unit, Raymond Poincaré Hospital, APHP

  • Djillali ANNANE, MD, PhD · General Intensive care Unit, Raymond Poincaré Hospital, APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404400 on ClinicalTrials.gov