Overview
Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis.
Description
Primary outcome:
- Hospital survival
Secondary outcomes:
- Duration of vasopressor therapy
- Requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI)
- ICU length of stay (LOS)
- Change in serum procalcitonin (PCT) over first 72 hours
- Change in SOFA score over first 72 hours (measured as SOFA score daily for four days, with day one being admission, then 3 days after, totaling 4 days of treatment with HAT)
- Procalcitonin clearance (formula = initial PCT - 72 hour PCT divided by initial PCT x 100)
- Number of wound related surgeries
- Wound status at time of hospital discharge:
- Open
- Closed
Eligibility
Inclusion Criteria:
- Necrotizing soft tissue infection by clinical diagnosis and requiring surgical treatment.
- Sepsis by clinical diagnosis and/or by Sepsis-3 criteria15, with source attributed to the wound.
- Anticipated or confirmed intensive care unit
Exclusion Criteria: (Adapted from Sevransky et. al's VICTAS protocol)
- Age < 18 years of age
- Weight < 40 kg
- Prior enrollment in this study or current enrollment in another study of any kind
- Surgical findings, pathology/histology findings, or other findings determined to be inconsistent with an infectious acute NSTI such that the clinical diagnosis is no longer that of a NSTI
- Sepsis deemed unlikely
- Limitations of care during enrollment [defined as refusal of cardiovascular and respiratory support modes described in inclusion criteria, including "do not intubate" (DNI) status and comfort care]
- Known allergy or known contraindication to vitamin C, thiamine, or corticosteroids [including previous history or active diagnosis of primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (G6PD) deficiency]
- Use of vitamin C at a dose of >1g/day (IV or oral) within the 24 hours preceding first episode of qualifying organ dysfunction during a given Emergency Department or Intensive Care Unit admission
- Chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of < 30 days unrelated to current sepsis diagnosis (e.g., stage IV malignancy, neurodegenerative disease, etc.)
- Kidney Stone(s) of any kind
- History of Oxalate Kidney Stone(s)
- Pregnancy or known active breastfeeding
- Prisoner or Incarceration
- Inability or unwillingness of subject or legal surrogate/representative to give written informed consent