Lessening Organ Dysfunction With VITamin C in Septic ARDS
Status:
Not yet recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study aims 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 intensive care unit (ICU) patients.
As secondary objectives, the study aims:
- To compare the effect of high-dose intravenous vitamin C vs. placebo on:
1. 6-month mortality;
2. 6-month HRQoL;
3. organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU);
4. global tissue dysoxia (at baseline);
5. oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14,
and 28 if in ICU, and if still intubated);
6. occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease:
Improving Global Outcomes) criteria20;
7. acute hemolysis as defined by:
- clinician judgment of hemolysis, as recorded in the chart, or
- hemoglobin drop of at least 25 g/L within 24 hours of a dose of
investigational product PLUS 2 of the following:
- reticulocyte count >2 times upper limit of normal at clinical site lab;
- haptoglobin < lower limit of normal at clinical site lab;
- indirect (unconjugated) bilirubin >2 times upper limit of normal at
clinical site lab;
- lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical
site lab.
Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of
packed red blood cells;
8. hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8
mmol/L.
- To assess baseline vitamin C levels in study participants (before the first dose of
investigational product).