View clinical trials related to Septic.
Filter by: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).
The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.