Phase 3
N=125
Vitamin C and Septic Shock
Septic Shock · Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT03338569 ↗Enrolled (actual)
125
Serious AEs
5.6%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With ICU Mortality — 20; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin C (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With ICU Mortality |
20; 14 | — |
| PRIMARY All Cause Mortality at 28 Days |
26; 16 | — |
| SECONDARY Duration of Vasopressor Therapy |
27.1; 27.7 | — |
| SECONDARY Duration of ICU Stay Post Intervention Administration |
2.6; 2.9 | — |
| SECONDARY Time to Lactate Clearance Post Intervention Administration |
— | — |
| SECONDARY Rate of Lactate Clearance Post Intervention Administration |
13; 12; 18; 16; 18; 18 | — |
| SECONDARY Rate of Procalcitonin Clearance Post Intervention Administration |
— | — |
| SECONDARY Number of Participants With Need for Renal Replacement Therapy |
2; 10 | — |
| SECONDARY Change in Serum Creatinine |
0.5; .4 | — |
| SECONDARY Change in Sequential Organ Failure Assessment (SOFA) Score |
4; 4 | — |
| SECONDARY Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores |
7; 5 | — |
| SECONDARY Total Intravenous Fluid Administered |
.76; 1.07; 3.37; 3.59 | — |
Summary
This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.
Eligibility Criteria
Inclusion Criteria
- • Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
- Age ≥ 18 years
- Septic shock as pragmatically defined as:
o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
- Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
- Lactate > 2 mmol/L 24 hr prior to enrollment AND
- Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.
- SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.
- qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.
Exclusion Criteria
- • Unable to start infusion within 24 hours of septic shock identification
- Currently pregnant or breastfeeding
- Patient to receive comfort measures only
- Cardiac Arrest
- Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics < 48 hours post-operation
- Participation in another study involving an investigational product within 30 days of the baseline visit
- Allergy to Vitamin C
- History of nephrolithiasis
- History of G6PD deficiency
- ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation
- Clinical course that treating clinician decides would preclude safe participation
Data sourced from ClinicalTrials.gov (NCT03338569). 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.