Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

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.

Timeline

Start

2022-02-17

Primary completion

2026-02

Completion

2026-02

Publications

• Background Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21.
• Background Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
• Heming N, Baron E, Muller G, Badie J, Preau S, Siami S, Pouplet C, Berger A, Damoisel C, Argaud L, Rigaud JP, Lambiotte F, Klouche K, Bruel C, Clere-Jehl R, Darmon M, Maizel J, Quenot JP, Robin C, Fleuriet J, Jacota M, Paoletti X, Annane D; HORNBILL consortium; CRICS-TRIGGERSEP network. HydrOcortisone and fludRocortisoNe for critical ILLness-related corticosteroid insufficiency (HORNbILL): study protocol for a multicentre randomised placebo-controlled trial. BMJ Open. 2026 Jun 17;16(6):e119187. doi: 10.1136/bmjopen-2026-119187.

Drugs

Indications