2024-516394-78-00招募中3 期
LOVIT-ARDS - A Multicentre Concealed‐Allocation Parallel‐Group Blinded Randomized Controlled Trial to Ascertain the Effect of High‐Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ Dysfunction at 28 Days in Septic ARDS Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 12
- 主要终点
- Death or persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) at 28 days
研究概览
简要总结
To compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction – defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors – assessed at 28 days on ICU patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years old
- •Admitted to the ICU with proven or suspected infection as the main diagnosis
- •Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine, angiotensin, others))
- •Currently treated with high flow oxygen, CPAP OR NIV OR Invasive Ventilation
- •Presenting with Acute Respiratory Distress Syndromedefined by all the following criteria: o Acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome o Bilateral opacities on chest imaging not explained by other pulmonary pathologies (e.g. pleural effusion, atelectasis, nodules, etc.) o No evidence for heart failure or volume overload o PaO2/FiO2 ≤ 200 mm Hg o PEEP ≥ 5 cm H2O
- •Patient who has signed an informed and written consent whenener he/she is capable of consent, if not, Patient’s representant signed consent whenever he/she is present at inclusion
- •Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
- •Patients under guardianship or curatorship can be included
- •Patients in case of simple emergency (legal definition) or vital emergency will be included
排除标准
- •48 hours from diagnosis of ARDS
- •Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition (PN) in doses standard for PN
- •Expected death or withdrawal of life-sustaining treatments within 48 hours
- •Previously enrolled in this study
- •Previously enrolled in an interventional trial for which co-enrolment is not allowed (co-enrolment to be determined case by case)
- •Patient with critical COVID-19 according WHO definition
- •Cardio-pulmonary resuscitation (CPR) in the past 72 hours
- •Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Pregnancy and breast-feeding
- •Hyperoxaluria
- •Known allergy excipients of vitamin C solution; or to one of the excipients in particular methyl parhydroxybenzoate (E218) or propyl (E216)
- •Treatment with Deferoxamine
- •Known kidney stones within the past 1 year
结局指标
主要结局
Death or persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) at 28 days
Death or persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) at 28 days
次要结局
未报告次要终点
研究者
Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (12)
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