Идёт набор NCT07451886

Adjunctive Fludrocortisone in Septic Shock

Фаза II С лечением Sepsis Septic Shock Sepsis - to Reduce Mortality in the Intensive Care Unit Sepsis and Septic Shock

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Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Fludrocortisone 100 mcg daily, Placebo.
Кому может быть актуально: Состояния в реестре: Sepsis, Septic Shock, Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis and Septic Shock. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Гонконг
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)

Обзор

Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone. To test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.

Подробное описание

Design: Pilot, multicenter, randomized, double-blind, placebo-controlled trial on use of adjunctive fludrocortisone in critically ill patients with septic shock.

Objective: Determine feasibility of conducting a large, international, multicenter, double-blind, randomized, placebo controlled efficacy trial of adjunctive fludrocortisone to improve septic shock mortality.

Setting: 6 intensive care units (ICU) in Hong Kong, Australia and Singapore. Participants: 32 adult participants with suspected or confirmed septic shock within 24 hours of onset of shock and mechanical ventilation. Exclusion criteria are pregnancy, limitation of therapy, prescribed fludrocortisone for other medical condition, fludrocortisone cannot be administered within 24 hours of shock onset.

Interventions: Enteral 100 mcg fludrocortisone daily or placebo for up to 7 days or until death or discharge from ICU, whichever comes first.

Main outcome measures: Primary outcome is fulfillment of all pre-specified endpoints of feasibility criteria: protocol deviation \<15%, lost of concealment \<10%, drop out rate \<10% and missing data \<10%. Secondary outcomes include monthly recruitment rate, time to resolution of shock, 28-day mortality, days alive and free from organ support, severe electrolyte abnormality.

Data analysis: Each feasibility criterion will be assessed amongst all study participants. Intention to treat analysis will be used to calculate differences in secondary outcomes between treatment groups.

Expected results: Feasibility criteria will be met and demonstrate potential to scale-up to a large, international, multicenter, double-blind, randomized, placebo-controlled trial of adjunctive fludrocortisone to improve septic shock mortality.

Вмешательства

Препарат Fludrocortisone 100 mcg daily
Patients will be given enteral fludrocortisone 100 mcg daily for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.
Препарат Placebo
Patients will be given an enteral placebo tablet for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.

Первичные конечные точки

Number of Protocol deviations < 15% [Срок оценки: End of study approximately 20 months]
Number of Lost of concealment < 10% [Срок оценки: End of study approximately 20 months]
Number of Drop out < 10% [Срок оценки: End of study approximately 20 months]
Number of Missing data < 10% [Срок оценки: End of study approximately 20 months]

Вторичные конечные точки (9)

Number of Monthly Recruitment [Срок оценки: End of study approximately 20 months]
Time to resolution of shock [Срок оценки: Until patient discharge from ICU]
28-day mortality [Срок оценки: First 28 days after enrollment]
Days alive and vasopressor-free until day 28 [Срок оценки: First 28 days after enrollment]
Days alive and ventilator-free until day 28 [Срок оценки: First 28 days after enrollment]
Days alive and dialysis-free until day 28 [Срок оценки: First 28 days after enrollment]
Days alive and free from organ support [Срок оценки: First 28 days after enrollment]
Number of new onset infections [Срок оценки: First 28 days after enrollment]
Severe electrolyte abnormality [Срок оценки: First 7 days after enrollment]

Критерии участия

Критерии включения

suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour
onset of septic shock within 24 hours
shock due to infection with no other proven or apparent cause
hypoperfusion defined as arterial or venous lactate concentration >2.0 mmol/L
mechanical ventilation