Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock

Официальное название

Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Hydrocortisone plus Fludrocortisone
  Hydrocortisone will be administered at a dose of 200 mg per day by continuous intravenous infusion. Fludrocortisone will be administered at a dose of 50 μg once daily orally or via nasogastric tube. Both drugs will be given for up to 7 days or until ICU discharge, whichever occurs first.
• Другое Standard care
  Patients will receive standard care for septic shock according to current international and institutional guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures. Fludrocortisone will not be administered.Hydrocortisone may be administered at the discretion of the treating physician.

Первичные конечные точки

• 90-day mortality [Срок оценки: 90 days after randomization]

Вторичные конечные точки (3)

• 28-day mortality [Срок оценки: 28 days after randomization]
• ICU mortality [Срок оценки: From randomization to ICU discharge (up to 90 days)]
• Hospital mortality [Срок оценки: From randomization to hospital discharge (up to 90 days)]

Критерии участия

Критерии включения

(1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h.

Критерии исключения

Patients meeting any of the following conditions will be excluded:

• Systemic corticosteroid therapy within the last 3 months before septic shock;
• High-dose steroid therapy;
• Immunosuppression;
• Pregnant;
• Known allergy to hydrocortisone or fludrocortisone;
• Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting;
• Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
• Refusal of the attending staff or patient family;
• Current participation in another clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Northern Jiangsu People's Hospital — Yangzhou

Идентификаторы

NCT: NCT07383103 · 2025ky387

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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