Phase 2
N=120
Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Sepsis · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT03592277 ↗Enrolled (actual)
120
Serious AEs
30.2%
Results posted
Sep 2022
Primary outcome: Primary: Mortality Rates — 12; 7 Participants — p=0.344
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin C (Drug); Vitamin B1 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trinity Health Of New England
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Rates |
12; 7 | 0.344 |
| SECONDARY Hospital Length of Stay |
8.5; 7.0 | 0.526 |
| SECONDARY Intensive Care Unit Length of Stay |
3.5; 3.0 | 0.123 |
| SECONDARY Readmission Rate |
17; 15 | 0.660 |
| SECONDARY Ventilator Days |
2.6; 2.3 | 0.745 |
| SECONDARY Hours on Vasopressors |
50.0; 35.9 | 0.236 |
Summary
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.
Eligibility Criteria
Patients must meet all inclusion criteria:
- Between the ages of 18 and 90 years old
- Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines.
- Weight more than 30 kg
- Full code
Exclusion Criteria
- Not diagnosed with severe sepsis or septic shock
- Younger than 18 or older than 90 years old
- With a history of nephrolithiasis
- Who are pregnant
- Weigh less than 30 kg
- Not located in the ICU
- Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
- Currently on dialysis
Data sourced from ClinicalTrials.gov (NCT03592277). 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.