Phase 2
N=140
Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
Sepsis, Severe · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT03422159 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Time to Vasopressor Independence (Hours) — 27; 53 hours — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ascorbic Acid (Drug); Thiamine (Drug); Hydrocortisone (Drug); Sodium Chloride 0.9% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Community Medical Center, Toms River, NJ
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Vasopressor Independence (Hours) |
27; 53 | <0.001 sig |
| PRIMARY Change in Sequential Organ Failure Assessment (SOFA) Score |
2.9; 1.93 | — |
| SECONDARY Procalcitonin (PCT) Clearance |
63; 58 | — |
| SECONDARY ICU Mortality |
6; 10 | — |
| SECONDARY ICU Length of Stay |
4.76; 4.66 | — |
| SECONDARY Ventilator Free Days |
22; 22.4 | — |
| SECONDARY Hospital Length of Stay |
11.5; 11 | — |
| SECONDARY Hospital Mortality |
11; 13 | — |
Summary
This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine, and hydrocortisone to the usual standard of care of sepsis and septic shock. Sepsis is a possibly life-threatening condition in which a patient may have organ dysfunction due to an infection. Septic shock is defined as low blood pressure and organ dysfunction that do not improve after administering IV fluids. Standard of care for sepsis and septic shock include early administration of IV antibiotics, IV fluids, and vasopressors if need be to provide oxygen to vital organs.
A large amount of experimental data has shown that vitamin C and corticosteroids decrease the release of inflammatory substances which may lead to organ failure seen in sepsis. Vitamin C and corticosteroids also improve blood flow to vital organs and increase the body's ability to respond well to vasopressor medications used in septic shock. Low blood levels of both thiamine and vitamin C are common in sepsis. The study will be placebo controlled, meaning one group will receive vitamin C, thiamine, and hydrocortisone, and the other will receive an inactive substance ("placebo"). The goal of the study is to compare the effects of receiving vitamin C, thiamine, and hydrocortisone (along with the standard sepsis care) versus placebo and standard sepsis care.
Eligibility Criteria
Inclusion Criteria
i. Diagnosis of sepsis or septic shock within 12 hours of admission to the ICU ii. Informed consent as dictated by IRB and local practice. iii. Compliance with the 3 hour sepsis bundle
- 30ml/kg of intravenous crystalloid fluid (e.g.: sodium chloride 0.9%) for lactic acid >4 and/or systolic blood pressure 24 hours after admission
Data sourced from ClinicalTrials.gov (NCT03422159). 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.