Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury



Status:Completed
Conditions:Hospital, Hospital, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:April 2014
End Date:January 8, 2018

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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).


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: <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 noninvasely with CPAP to diagnose mild ARDS

Exclusion Criteria:

- 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)
We found this trial at
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Lexington, Kentucky
859) 257-9000
Phone: 859-323-5045
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Duncan Hite, MD
Phone: 216-445-3098
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Atlanta, Georgia
Principal Investigator: Greg Martin, MD, MSc
Phone: 404-616-0148
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Atlanta, GA
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: Jonathon Truwit, MD
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Milwaukee, WI
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Richmond, Virginia 23298
Principal Investigator: Alpha (Berry) Fowler, MD
Phone: 804-628-5710
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Richmond, VA
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