Phase 2
N=24
Ascorbic Acid (Vitamin C) Infusion in Human Sepsis
Sepsis · Septic Shock · Hypotension · Acute Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT01434121 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ascorbic Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients |
0; 0; 0 | — |
| SECONDARY Intensive Care Unit Length of Stay |
— | — |
| SECONDARY Duration of Mechanical Ventilation |
— | — |
| SECONDARY Ventilator-free Days |
— | — |
| SECONDARY Length of Time on Vasopressor Medication |
— | — |
| SECONDARY Multiple Organ Dysfunction Score |
— | — |
| SECONDARY Plasma Cytokine/Chemokine Levels |
— | — |
Summary
The major goal of this project is to determine whether intravenously infused ascorbic acid is safe for use as a viable therapeutic strategy in adult humans with sepsis.
Eligibility Criteria
Inclusion Criteria
- systemic inflammatory response: fever (38°C or greater) or hypothermia (36°C or lower), tachypnea (20 breaths/min) or need for mechanical ventilation for an acute process, tachycardia (rate 90/min or more), white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 or more than 10% band forms.
- Presumed or Known Site of Infection: Purulent sputum, chest radiograph with new infiltrate, spillage of bowel contents, radiographic or physical examination evidence of an infected collection, white blood cells in a normally sterile body fluid, positive blood culture, evidence of infected mechanical hardware by physical, radiographic, or ultrasonographic evidence.
- Evidence of Dysfunction of One or More End Organs: cardiovascular dysfunction: mean arterial pressure 60 mm Hg or less, the need for vasopressors to maintain this pressure in the presence of adequate intravascular volume (central venous pressure 12 mmHg); respiratory failure: (arterial PO2-to-FiO2 ratio of less than 250 or less than 200 in the presence of pneumonia; renal dysfunction: Urine output ≤ 0.5 ml/kg/hr for 2 hours in the presence of adequate intravascular volume or doubling of the serum creatinine; hematologic dysfunction: thrombocytopenia ≤ 80,000 platelets/mm3 or 50% decrease from baseline during the acute illness; Unexplained metabolic acidosis: arterial pH ≤ 7.3 and a plasma lactate level higher than 2.5. Hepatic Dysfunction: Acute Serum transaminase elevation greater than five times normal.
- Informed Consent: Ability to obtain informed consent within 48 hours.
Exclusion Criteria
- Demographic Characteristics: Children (age < 18 years), pregnant women, prisoners, and other wards of the state are excluded from participation in this study.
- Informed Consent: Inability to obtain informed consent within 48 hours.
- Cognitive Impairment: In the absence of family or next of kin, if the investigators feel the patient is cognitively impaired, and unable to provide informed consent, the patient will not be accessed to the study.
- Non-English Speaking Patients: Patients who are non english speaking will not be accessed to this study.
Data sourced from ClinicalTrials.gov (NCT01434121). 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.