ascorbic acid
DrugIntervention
Other names: Vitamin C
NCT Number: NCT02106975
Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ failure as measured by Sequential Organ Failure Assessment (SOFA) score,
Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by the oxygenation index and the VE40
Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a fibrinolytic state (Tissue Factor Pathway Inhibitor).
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Emory University and Grady Memorial Hospital, Atlanta, Georgia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention
Other names: Vitamin C
Placebo
Time frame: 96 hours
mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.
Time frame: up to 168 hours
Time frame: Up to 168 hours
Time frame: Up to hour 168
Time frame: Up to hour 168
Estimate of Shunt
Time frame: Up to hour 96
mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.
Time frame: Up to hour 168
Time frame: Up to Day 28
Time frame: Up to Day 28
Time frame: Up to Day 28
Time frame: Up to Day 60
Time frame: Up to hour 168
Time frame: Up to hour 168
Time frame: Up to hour 168
Time frame: Up to hour 168
Oxygenation as measure by the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Scores range from 100 to 300 with lower values indicating more worse outcomes
Time frame: Up to hour 168
Oxygenation as measure by the ratio of arterial oxygen saturation to fraction of inspired oxygen SpO2/FiO2
Time frame: Up to hour 168
Coagulation as measured by Platelets per unit of blood. Scores range from less than 20 to more than 150. Lower scores indicate worse outcomes
Time frame: Up to hour 168
Liver function as measured by Total Bilirubin. Normal levels range from 0.2 - 1.2. Levels greater than 1.2 indicate worse outcomes
Time frame: Up to hour 168
Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.
Time frame: Up to hour 168
State of consciousness as measure by Glasgow Coma Scale which gives a score based on eye, verbal, and motor responses. Scores range from 3 to 15 with lower scores indicating worse outcome
Time frame: Up to hour 168
Renal function as measured by Creatinine. Scores range from less than 1.2 to greater than 5.0 with higher scores indicating worse outcomes
Virginia Commonwealth University
Other
Acronym: CITRIS-ALI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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