essening Organ Dysfunction with VITamin C (LOVIT)

Phase 1

• Conditions: Sepsis; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-003350-80-FR
• Lead Sponsor: niversité de Sherbrooke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

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);

In France:
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

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified