Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Lung Injury, Sepsis

In brief

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).

Key facts

Study ID

NCT02106975

Run by

Virginia Commonwealth University

People needed

170

Starts

2014-04-01

Expected to finish

2018-01-08

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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: <36ºC (core temp only), tachycardia: heart rate > 90 beats/min or receiving medications that slow heart rate or paced rhythm, leukocytosis: >12,000 WBC/µL or leukopenia: <4,000 WBC/µL or >10% band forms. Respiratory rate > 20 breaths per minute or PaCO2 < 32 or invasive mechanical ventilation.
• The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection)
• Sepsis associated hypotension (systolic blood pressure (SBP) < 90 mm Hg or an SBP decrease > 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 < 300) or supplemental O2 > 6LPM.
• Lactate > upper limits of normal laboratory results
• Urine output < 0.5 ml/kg/hour for > two hours despite adequate fluid resuscitation
• Platelet count < 100,000 per mcL
• Coagulopathy (INR > 1.5)
• Bilirubin > 2 mg/dL
• Glasgow Coma Scale < 11 or a positive CAM ICU score
• ARDS characterized by all the following criteria
• Lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms
• Bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules)
• Respiratory failure not explained by heart failure or volume overload
• Decreased arterial PaO2/FiO2 ratio ≤ 300 mm Hg
• Minimum PEEP of 5 cmH2O (may be delivered noninvasively with CPAP to diagnose mild ARDS

You may not qualify if…

• Known allergy to Vitamin C
• inability to obtain consent;
• age < 18 years;
• No indwelling venous or arterial catheter in patients requiring insulin in a manner that requires glucose being checked more than twice daily (e.g. continuous infusion, sliding scale);
• presence of diabetic ketoacidosis;
• more than 48 hrs since meeting ARDS criteria;
• patient or surrogate or physician not committed to full support (not excluded if patient would receive all supportive care except for cardiac resuscitation);
• pregnancy or breast feeding,
• moribund patient not expected to survive 24 hours;
• home mechanical ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing;
• home O2 > 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)

Where it is running

• Emory University and Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Kentucky — Lexington, Kentucky, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Froedtert and The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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