HAT for the Treatment of Sepsis Associated With NASTI

Sepsis Clinical Trial

Official title:

Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05157360
• Other study ID #: KUVC1814
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 10, 2021
• Est. completion date: May 16, 2023

Study information

• Verified date: March 2024
• Source: Ascension Via Christi Hospitals Wichita, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Necrotizing Soft Tissue Infection
• Sepsis
• Soft Tissue Infections
• Toxemia

Intervention

Drug:
• HAT
hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT
• Placebo
normal saline solution

Locations

Country	Name	City	State
United States	Ascension Via Christi Hospital - St. Francis Campus	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Ascension Via Christi Hospitals Wichita, Inc.	The University of Kansas School of Medicine - Wichita

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Survival	Hospital survival is a binary variable showing whether the patient survived their time in the hospital. Hospital survival will be assessed from date of randomization until the date of discharge or date of death from any cause, whichever comes first, assessed up to 24 months.	Outcome is measured from date of randomization to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	Duration of vasopressor therapy	The duration of vasopressor therapy is measured after date of randomization in hours and minutes from the initiation of vasopressor therapy until the termination of vasopressor therapy.	Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	Requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI)	This is a binary variable the will record whether the patient did or did not have a requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI).	Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	ICU length of stay (LOS)	ICU LOS will be measured by the date and time the patient was admitted to the ICU and by the date and time the patient was discharged from the ICU.	Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	Change in serum procalcitonin (PCT) over first 72 hours	This is a binary variable that will show whether there was a change in serum procalcitonin (PCT) over first 72 hours.	Over the first 72 hours from admission.
Secondary	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)	This is a group of variables that will show whether there was a change in SOFA score over the 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).	Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	Procalcitonin Clearance	Procalcitonin clearance (formula = initial PCT - 72 hour PCT divided by initial PCT x 100)	Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	Number of wound related surgeries	This is a variable that will show the count of wound related surgeries during the time the patient is admitted to the hospital.	Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
Secondary	Wound status at time of hospital discharge: Open or Closed	This is a binary variable that shows whether the wound status at time of hospital discharge is open or closed.	Assessed at the time of discharge for each individual patient. Patients will be discharged throughout the study so this measure will be assessed up to 24 months.