EUCTR2020-000296-21-FR进行中（未招募）1 期
Rapid rEcognition of COrticosteroid Resistant or sentive Sepsis RECORDSA Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy - RECORDS
ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 1,800 人开始时间: 2020年3月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients = 18 years old,
- •2) Admitted to the ICU with proven or suspected infection as the main diagnosis,
- •3) Community acquired pneumonia related sepsis OR vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) OR septic shock (Singer 2016: vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) OR acute respiratory distress syndrome (ARDS – Ranieri 2012: a- acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome, b- bilateral opacities on chest imaging not explained by other pulmonary pathologies, e.g. pleural effusion, atelectasis, nodules etc, c- no evidence for heart failure or volume overload, d- PaO2/FiO2 = 300 mm Hg, - PEEP = 5 cm H2O
- •4) Patient who has signed an informed and written consent whevener he/she is able of consent, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion
- •5) Patients who have been tested for RECORDS specific biomarkers
- •oCIRCI negative
- •oEndocan < 2 ng/L
- •oGILZ < x (threshold currently under study)
- •oCPD positive
- •oTranscriptomic SRS2
- •oEndotype B
- •6) Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU);
- •7) Patients under guardianship or curatorship will be included;
- •8) Patients in case of simple emergency (legal definition) will be included.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
排除标准
- •1) Pregnancy
- •2) Expected death or withdrawal of life-sustaining treatments within 48 hours
- •3) Previously enrolled in this study or in an other ineterventional study,
- •4) Hypersensitivity to hydrocortisone or fludrocortisone or any of their excipients ( SPC),
- •5) Women of childbearing potential not using contraception,
- •6) Nursing women.
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