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Trial - NCT03680274


Column Value
Trial registration number NCT03680274
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT03680274

First author
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov

François Lamontagne, MD FRCPC MSc; Neill Adhikari, MDCM FRCPC MSc

Contact
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov

Marie-Helene Masse, marie-helene.masse3@usherbrooke.ca (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

24/03/2020

Recruitment status
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: admitted to the intensive care unit with proven or suspected infection as the main diagnosis; currently treated with a continuous iv infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine).

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

> 24 hours of intensive care unit admission; known glucose-6-phosphate dehydrogenase (g6pd) deficiency; pregnancy; known allergy to vitamin c; known kidney stones within the past 1 year; received any intravenous vitamin c during this hospitalization unless incorporated in parenteral nutrition; expected death or withdrawal of life-sustaining treatments within 48 hours; previously enrolled in this study; previously enrolled in a trial with which co-enrolment is not allowed. the lovit trial has broad eligibility criteria and includes patients with a primary diagnosis of sepsis of any cause (including sepsis caused by viral pathogens as covid-19).

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Université de Sherbrooke

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

872

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Number of deceased participants or with persistent organ dysfunction

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]