Phase 2
N=167
Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
Acute Lung Injury · Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT02106975 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Modified Change in Sequential Organ Failure Assessment (mSOFA) Score — -2.96; -3.20 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ascorbic Acid (Drug); Placebo: 5% Dextrose in water (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Change in Sequential Organ Failure Assessment (mSOFA) Score |
-2.96; -3.20 | — |
| PRIMARY C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo |
109; 119; 80; 84; 56; 59 | — |
| PRIMARY Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo |
14; 14; 15; 15; 15; 15 | — |
| SECONDARY Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo. |
11; 10; 7; 7; 9; 7 | — |
| SECONDARY VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo |
127; 121; 127; 123; 127; 114 | — |
| SECONDARY mSOFA Scores at Hours 0, 48, 96 |
10; 10; 9; 8; 6; 6 | — |
| SECONDARY Ascorbate Level at Hour 0, 48, 96, 168 |
25; 26; 301; 24; 397; 26 | — |
| SECONDARY Ventilator Free Days to Day 28 |
13; 11 | — |
| SECONDARY ICU-free Days at Day 28 |
11; 8 | — |
| SECONDARY All Cause Mortality to Day 28 |
30; 46 | — |
| SECONDARY Hospital-free Days at Day 60 |
23; 15 | — |
| SECONDARY Procalcitonin at Study Hour 0, 48, 96, 168 |
12; 27; 7; 9; 3; 4 | — |
| SECONDARY Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168 |
6; 7; 4; 4; 4; 3 | — |
| SECONDARY Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168 |
46; 43; 42; 42; 42; 44 | — |
| SECONDARY Oxygenation Score: Pressure |
189; 214; 233; 246; 226; 244 | — |
| SECONDARY Oxygenation Score: Saturation |
168; 177; 231; 220; 250; 244 | — |
| SECONDARY Coagulation |
173; 175; 171; 147; 182; 165 | — |
| SECONDARY Liver Function |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Cardiovascular Function |
73; 73; 78; 79; 84; 84 | — |
| SECONDARY State of Consciousness |
8; 7; 9; 9; 10; 10 | — |
| SECONDARY Renal Function |
1; 2; 2; 1; 1; 1 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Patients must have suspected or proven infection, and meet 2 out of 4 of the criteria for Systemic Inflammatory Response (SIRS) due to infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).
- Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system, see Appendix A).
- The presence of a systemic inflammatory response: Defined as: fever: >38ºC (any route) or hypothermia: 90 beats/min or receiving medications that slow heart rate or paced rhythm, leukocytosis: >12,000 WBC/µL or leukopenia: 10% band forms. Respiratory rate > 20 breaths per minute or PaCO2 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/> 5mcg, phenylephrine, vasopressin)
- Arterial hypoxemia (PaO2/FiO2 6LPM.
- Lactate > upper limits of normal laboratory results
- Urine output two hours despite adequate fluid resuscitation
- Platelet count 1.5)
- Bilirubin > 2 mg/dL
- Glasgow Coma Scale 2LPM, except for with CPAP/BIPAP
- diffuse alveolar hemorrhage (vasculitis);
- interstitial lung disease requiring continuous home oxygen therapy;
- Active kidney stone
- Non English speaking;
- Ward of the state (inmate, other)
Data sourced from ClinicalTrials.gov (NCT02106975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.