Early intravenous hydrocortisone in sepsis: A randomized control trial (Protocol): Early intravenous hydrocortisone in sepsis

Wasin Pansiritanachot; Chairat Permpikul; Surat Tongyoo; Tipa Chakorn; Patimaporn Wongprompitak; Sansnee  Senawong

doi:10.54205/ccc.v32.267616

Authors

Wasin Pansiritanachot Department of Emergency Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0001-6285-8326
Chairat Permpikul Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0001-5491-6987
Surat Tongyoo Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0003-3772-2990
Tipa Chakorn Department of Emergency Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0002-9931-4231
Patimaporn Wongprompitak Department of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0003-3740-8643
Sansnee Senawong Department of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0001-5721-6230

DOI:

https://doi.org/10.54205/ccc.v32.267616

Keywords:

Corticosteroids, Sepsis, Hydrocortisone, Shock

Abstract

Background: The evidence of the appropriate timing of hydrocortisone is still weak and controversial. Observational studies showed a trend towards greater benefits when hydrocortisone was given earlier in the course of septic shock resuscitation. This study evaluates the effects of early intravenous low-dose hydrocortisone administered at the beginning of the onset of sepsis-induced hypotension compared with standard care.

Methods: This study is a single-center, parallel-group, double-blinded, randomized control trial, conducted in a non-trauma emergency department. Adult patients with sepsis-induced hypotension will be included. Patients will be randomly assigned in a 1:1 ratio to receive early intravenous low-dose hydrocortisone or standard care. Blood inflammatory biomarkers at baseline will be collected. The primary outcome is 28-day mortality. Resuscitation-related secondary outcomes and safety outcomes will also be observed. Outcomes will be compared between groups. Subgroup analyses considering inflammatory biomarker levels will also be performed to evaluate the effect of early intravenous hydrocortisone, especially in patients with hyperinflammation.

Hypothesis: We hypothesize that early intravenous low-dose hydrocortisone administration in patients with sepsis-induced hypotension would result in less mortality and improve resuscitation outcomes, especially in subgroup of patients with hyperinflammation.

Ethics and dissemination: The study protocol was approved by the Siriraj Institutional Review Board with the certificate of approval number Si 917/2023.

Trial registration: Clinicaltrial.gov NCT06217939

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Early intravenous hydrocortisone in sepsis: A randomized control trial (Protocol)