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Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock:A Prospective Randomized Controlled Clinical Trial
The purpose of this study is to evaluate the efficacy and safety of the combination therapy of hydrocortisone and fludrocortisone among adult patients with septic shock.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, and septic shock represents its most severe form, characterized by profound circulatory and metabolic abnormalities with high mortality. Current international guidelines recommend intravenous hydrocortisone as adjunctive therapy in patients with septic shock who remain hypotensive despite adequate fluid resuscitation and vasopressor treatment. However, critically ill patients may exhibit relative deficiencies of both glucocorticoid and mineralocorticoid activity, and hydrocortisone alone may not fully meet the physiological demands under severe stress. In recent years, combination therapy with hydrocortisone and fludrocortisone has been investigated, but published trials have reported inconsistent results regarding mortality, shock reversal, and adverse events. Therefore, this randomized controlled trial aims to evaluate the efficacy and safety of hydrocortisone combined with fludrocortisone, compared with standard therapy, in patients with septic shock.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Start Date
March 2, 2026
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2028
Last Updated
March 4, 2026
336
ESTIMATED participants
Hydrocortisone plus Fludrocortisone
DRUG
Standard care
OTHER
Lead Sponsor
Northern Jiangsu People's Hospital
NCT07179276
NCT07388628
Data Source & Attribution
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