Clinical trial NCT05157360: HAT for the Treatment of Sepsis Associated With NASTI
Official title: Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Necrotizing Soft Tissue Infection
Sepsis
Lead sponsor: Ascension Via Christi Hospitals Wichita, Inc.
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2021-12-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Primary outcome:

1. Hospital survival

Secondary outcomes:

1. Duration of vasopressor therapy
2. Requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI)
3. ICU length of stay (LOS)
4. Change in serum procalcitonin (PCT) over first 72 hours
5. 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)
6. Procalcitonin clearance (formula = initial PCT - 72 hour PCT divided by initial PCT x 100)
7. Number of wound related surgeries
8. Wound status at time of hospital discharge:

   1. Open
   2. Closed

Eligibility 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Duration of Vasopressor Therapy
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
measure: Requirement for Renal Replacement Therapy in Patients With Acute Kidney Injury (AKI)
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
measure: ICU Length of Stay (LOS)
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
measure: Change in Serum Procalcitonin (PCT) Over First 72 Hours
timeFrame: Over the first 72 hours from admission.
measure: Change in Sequential Organ Failure Assessment (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)
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
measure: Procalcitonin Clearance
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
measure: Number of Wound Related Surgeries
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
measure: Wound Status at Time of Hospital Discharge: Open
timeFrame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Ascension Via Christi Hospital - St. Francis Campus
state: Kansas
Study officials:
affiliation: Surgeon
name: Thomas Resch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: