Glucocorticoids in adults with acute respiratory distress syndrome: A randomised, parallel-group, allocation-concealed, open-label, pragmatic, group-sequential design, clinical and cost-effectiveness trial with internal pilot

niversity of Edinburgh0 个研究点目标入组 1,708 人开始时间: 2023年9月26日最近更新: 2024年3月25日

试验速览

暂无简介。

•1. Provision of informed consent
•2. Aged 16 years or older
•3. Admitted to intensive care unit or high dependency unit (ICU)
•4. Receiving respiratory support via invasive mechanical ventilation or non-invasive ventilatory support (non-invasive ventilatory support includes mask or helmet) or high flow nasal cannula (HFNC) >30L/min
•5. Within 72 hours of diagnosis of ARDS with moderate to severe hypoxaemia defined as
•6. Known acute clinical insult or new or worsening respiratory dysfunction (Note: this includes new deterioration at any time-point during the ICU stay), and
•6.1. Opacities on chest imaging not fully explained by effusions, lobar/lung collapse/atelectasis, or nodules, and
•6.2. Respiratory failure not fully explained by cardiac failure or fluid overload, and
•6.3. Assessment of hypoxaemia done with either PaO2/FiO2 ratio <26.7 kPa from arterial blood gases, or SpO2/FiO2 <235 with SaO2<97%

•1. ARDS due to microbiologically confirmed SARS-Co-V2 infection (COVID-19 ARDS)
•2. Major upper gastrointestinal bleeding during current hospital admission, defined as requiring endoscopy and transfusion for two or more units of packed red blood cells. This exclusion criterion will exclude patients with contraindications to glucocorticoids on safety grounds.
•3. High-dose glucocorticoids are required for a separate proven clinical indication at the time of randomisation as withholding treatments that have been deemed clinically effective, would be unethical.
•Note: Low-dose glucocorticoid treatments for clinical indications (defined as maximum daily dose of 200mg hydrocortisone or equivalent other steroids) is not an exclusion criterion.
•4. Known hypersensitivity to dexamethasone
•5. Infections that are not being effectively treated as determined by the treating medical team.
•Note: Once infections are considered as effectively treated by the treating medical team, they are eligible for the trial.
•6. Planned intensive care treatment withdrawal within next 24 hours as determined by the treating medical team
•7. Patients who are known to be pregnant
•8. Previous enrolment in the GuARDS trial

发起方

niversity of Edinburgh