EUCTR2019-003350-80-FR进行中(未招募)1 期
essening Organ Dysfunction with VITamin C (LOVIT) - LOVIT
niversité de Sherbrooke0 个研究点目标入组 800 人开始时间: 2019年11月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 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
入选标准
- •In both countries:
- •1) Patients = 18 years old;
- •2) Admitted to the ICU with proven or suspected infection as the main diagnosis;
- •3) Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine);
- •5) Patient (or his representant) who has signed an informed and written consent;
- •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 700
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1) > 24 hours of ICU admission;
- •2) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- •3) Pregnancy;
- •4) Known allergy to vitamin C; or to one of the excipients in particular methyl parahydroxybenzoate (E218) or propyl (E216);
- •5) Known kidney stones within the past 1 year;
- •6) Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition;
- •7) Expected death or withdrawal of life-sustaining treatments within 48 hours;
- •8) Previously enrolled in this study;
- •9) Previously enrolled in a trial for which co-enrolment is not allowed (co-enrolment to be determined case by case).
研究者
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