2024-516021-32-00招募中3 期
HORNbILL. HydrOcortisone and fludRocortisoNe for critical ILLness-related corticosteroid insufficiency
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,276
- 试验地点
- 19
- 主要终点
- The primary end point is the number of ventilator- and vasopressor-free days up to day 30, defined as days from randomisation to 30 days thereafter, during which the patient is alive, free of mechanical ventilation, and free of treatment with intravenous vasopressors.
研究概览
简要总结
To assess the efficacy on ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) post randomization of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years)
- •Hospitalized in an intensive care unit
- •SOFA score (SOFA; Sequential Organ Failure Assessment) ≥4, for at least 6 consecutive hours
- •Informed written consent from patient or from legally authorized trusted person or next of kin, if present at time of inclusion. When a patient is unable to be informed, and no legally authorized trusted person or next of kin is present, the patient may still be included (emergency procedure), and patient’s, or, where appropriate, the legally authorized trusted person or next of kin’s, deferred consent needs to be obtained as soon as possible (Article L1122-1-3; Public Health Code).
- •Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
排除标准
- •Any suspected or proven acute adrenal insufficiency (As defined in international guidelines; basal cortisol < 5 μg/dl or peak (T60) cortisol <18 μg/dL)
- •Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30days
- •Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
- •Pregnant or breastfeeding woman
- •Moribund patient
- •Previously enrolled in this study
- •Participation to another interventional study that focuses on CIRCI and/or corticoid drugs and/or that adresses a similar primary endpoint as Hornbill (survival or use of vasopressors or of mechanical ventilation)
- •Patient under guardianship or tutorship
- •Note:Included patients for whom acute adrenal insufficiency would be detected in the Synacthen ® test performed as part of the research for the diagnosis of CIRCI will not be randomized since they should be treated by corticosteroids.
- •Expected death or withdrawal of life-sustaining treatments within 48 hours
- •Known chronic adrenal insufficiency
- •Concomitant treatment that inhibits cortisol production
- •Septic shock (Singer Jama 2016)
- •Active tuberculosis or fungal infection
- •Active viral hepatitis or active infection with herpes viruses
- •Hypersensitivity to hydrocortisone, fludrocortisone or Synacthène® or any of their excipients (SmPC)
- •Patient needing either anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason (Such as those suffering from COVID-19 pneumonia requiring oxygen therapy)
结局指标
主要结局
The primary end point is the number of ventilator- and vasopressor-free days up to day 30, defined as days from randomisation to 30 days thereafter, during which the patient is alive, free of mechanical ventilation, and free of treatment with intravenous vasopressors.
The primary end point is the number of ventilator- and vasopressor-free days up to day 30, defined as days from randomisation to 30 days thereafter, during which the patient is alive, free of mechanical ventilation, and free of treatment with intravenous vasopressors.
次要结局
- Mortality rates at ICU and hospital discharge and at day 30, 90 and 180 after randomization
- Number of days alive without vasopressors on day 30 after randomization. Patients who die before vasopressor weaning will be considered as having 0 vasopressor free days.
- Number of days alive free of mechanical ventilation on day 30 after randomization. Patients who die before mechanical ventilation weaning will be considered as having 0 ventilator free days.
- Proportion of patients with a decision to withhold and/or withdraw active treatments
- Renal replacement therapy (RRT)-free days up to Day 30 after randomisation (excluding patients on RRT for chronic renal failure at time of randomisation)
- Number of days alive with SOFA <4 in the 30 days after randomization
- Number of 30-day intensive care unit (ICU)–free days
- ICU and hospital length of stay
- Rate of re-admission to the ICU during the 30 days after randomization
- Score of cutaneous vasoconstrictor response to glucocorticoids (before administration of the corticoid treatment at study or placebo)
- Change in utility, based on the EuroQol group’s 5-dimension 5-level (EQ-5D-5L) questionnaire, up to Day 30 and 90 after randomisation
- Safety endpoints
- Secondary endpoint concerning non-randomised patients: - Ventilation and vasopressors free days at day 30 post SYNACTHENE® test and all cause 90 day mortality post SYNACTHENE® test (assessed using the same definition as for the primary endpoint: see section 4.1.1 of protocol) in subjects devoid of CIRCI.
研究者
Nicholas HEMING Coordinator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (19)
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