HAT for the Treatment of Sepsis Associated With NASTI

• Status: Recruiting
• Trial end date: 2022-10-10
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascension Via Christi Hospitals Wichita, Inc.
• Collaborator: The University of Kansas School of Medicine - Wichita
• Treatments: Hydrocortisone; Vitamins

Criteria

Inclusion Criteria:

1. Necrotizing soft tissue infection by clinical diagnosis and requiring surgical treatment.

2. Sepsis by clinical diagnosis and/or by Sepsis-3 criteria15, with source attributed to the wound.

3. Anticipated or confirmed intensive care unit

Exclusion Criteria: (Adapted from Sevransky et. al's VICTAS protocol)

1. Age < 18 years of age

2. Weight < 40 kg

3. Prior enrollment in this study or current enrollment in another study of any kind

4. 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

5. Sepsis deemed unlikely

6. 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]

7. 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]

8. 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

9. 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.)

10. Kidney Stone(s) of any kind

11. History of Oxalate Kidney Stone(s)

12. Pregnancy or known active breastfeeding

13. Prisoner or Incarceration

14. Inability or unwillingness of subject or legal surrogate/representative to give written informed consent