TerminatedPhase 1/2

HAT for the Treatment of Sepsis Associated With NASTI

Stopped: slow recruitment and not anticipated to meet recruitment numbers

United States10 participantsStarted 2021-09-10

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Hospital Survival

Timeframe: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.

NCT IDNCT05157360

SponsorAscension Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-16

Results submitted2024-06-11

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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