HAT for the Treatment of Sepsis Associated With NASTI
Necrotizing Soft Tissue Infection, Sepsis
About this trial
This is an interventional treatment trial for Necrotizing Soft Tissue Infection
Eligibility Criteria
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
Sites / Locations
- Ascension Via Christi Hospital - St. Francis CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment Arm
Control Arm
Patients will be enrolled within 24 hours of diagnosis of sepsis related to a necrotizing soft-tissue infections (NSTI). HAT will be initiated within 4 hours of enrollment (thus treatment with HAT can occur no later than 28 hours from diagnosis). Per Dr. Marik's original study, HAT consists of: 1.5 g vitamin C every 6 hours for 4 days or until ICU discharge 50 mg hydrocortisone every 6 hours for 7 days or until ICU discharge (followed by a taper over 3 days) 200 mg thiamine every 12 hours for 4 days or until ICU discharge In our study, due to the prolonged ICU course typical of most patients with NSTIs, it is not felt feasible to continue indefinitely "until ICU discharge." Thus, treatment will be continued for 4 to 7 days plus a 3 day taper (respectively) as above, with no plan for a longer duration of treatment.
The control arm will receive the same standard ICU care for NSTI but will not receive HAT. They will receive a placebo consisting of normal saline, indistinguishable to the treatment team (blinded) but known to the pharmacy team (unblinded to treatment and placebo groups). This is so that if the treatment team elects to give stress dose steroids, they can be administered without breaking protocol (i.e. if the patient is getting HAT, it includes steroids, so if the treating team wanted to start hydrocortisone - because they didn't know if the patient was on HAT or placebo and felt steroids were indicated - the pharmacist could ensure the patient was on steroids one way or another without unblinding the providers).