跳至主要内容
临床试验/EUCTR2019-003350-80-FR
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

发起方
niversité de Sherbrooke

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