- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05157360
HAT for the Treatment of Sepsis Associated With NASTI
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary outcome:
1. Hospital survival
Secondary outcomes:
- Duration of vasopressor therapy
- Requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI)
- ICU length of stay (LOS)
- Change in serum procalcitonin (PCT) over first 72 hours
- 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)
- Procalcitonin clearance (formula = initial PCT - 72 hour PCT divided by initial PCT x 100)
- Number of wound related surgeries
Wound status at time of hospital discharge:
- Open
- Closed
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Thomas Resch, M.D.
- Phone Number: 316-263-0296
- Email: TResch@wsspa.com
Study Contact Backup
- Name: Stephen D. Helmer, Ph.D.
- Phone Number: 316-268-5457
- Email: Stephen.Helmer@Ascension.org
Study Locations
-
-
Kansas
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Wichita, Kansas, United States, 67214
- Ascension Via Christi Hospital - St. Francis Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment 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:
|
hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT
Other Names:
|
Placebo Comparator: Control Arm
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).
|
normal saline solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Survival
Time Frame: Outcome is measured from date of randomization to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
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Outcome is measured from date of randomization to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of vasopressor therapy
Time Frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
|
Requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI)
Time Frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
|
ICU length of stay (LOS)
Time Frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
|
Change in serum procalcitonin (PCT) over first 72 hours
Time Frame: Over the first 72 hours from admission.
|
This is a binary variable that will show whether there was a change in serum procalcitonin (PCT) over first 72 hours.
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Over the first 72 hours from admission.
|
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)
Time Frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
|
Procalcitonin Clearance
Time Frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
|
Number of wound related surgeries
Time Frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.
|
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.
|
Wound status at time of hospital discharge: Open or Closed
Time Frame: 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.
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This is a binary variable that shows whether the wound status at time of hospital discharge is open or closed.
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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.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas Resch, M.D., Surgeon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUVC1814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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