Necrotizing Soft Tissue InfectionPhase 1/2NCT05157360

HAT for the Treatment of Sepsis Associated With NASTI

A Phase 1/2 study testing HAT in people with Necrotizing Soft Tissue Infection and Sepsis, run by Ascension Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Necrotizing Soft Tissue Infection, Sepsis
What is being tested?: HAT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2021to 16 May 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ascension Via Christi Hospital - St. Francis Campus
Wichita, Kansas, 67214

Other trials in United States

About this study

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

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

Read the detailed description

Primary outcome:

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

Conditions: Necrotizing Soft Tissue Infection, Sepsis
Being tested: HAT, Placebo
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HATDrug
Also called hydrocortisone, vitamin C, vitamin B1
hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT
PlaceboDrug
Also called NaCl 0.9%
normal saline solution

Study groups in NCT05157360
Study group	Role	What they receive
Treatment Arm	Experimental	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: 1. 1.5 g vitamin C every 6 hours for 4 days or until ICU discharge 2. 50 mg hydrocortisone every 6 hours for 7 days or until ICU discharge (followed by a taper over 3 days) 3. 200 mg thiamine every 12 hours for 4 days or until ICU discharge In our study, due to the prolonged ICU course typical of most patients with NSTIs, it is not felt feasible to continue indefinitely "until ICU discharge." Thus, treatment will be continued for 4 to 7 days plus a 3 day taper (respectively) as above, with no plan for a longer duration of treatment. Receives: Drug: HAT
Control Arm	Placebo comparator	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). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (8)

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.
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
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).
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
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.
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
Change in Serum Procalcitonin (PCT) Over First 72 Hours
This is a binary variable that will show whether there was a decrease in serum procalcitonin (PCT) over first 72 hours.
Measured: 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)
This is a binary variable that will shows whether there was a decrease 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).
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
Procalcitonin Clearance
Procalcitonin clearance (formula = initial PCT - 72 hour PCT divided by initial PCT x 100). The reported measure is median and range for those patients that
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
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.
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
Wound Status at Time of Hospital Discharge: Open
This shows the number of participants with an open wound at time of hospital discharge.
Measured: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202116 May 2023

First posted15 Dec 2021
Study start10 Sep 2021
Primary completion16 May 2023
Study completion16 May 2023

Why it stopped: slow recruitment and not anticipated to meet recruitment numbers

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Necrotizing Soft Tissue InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05157360
Sponsor's protocol ID: KUVC1814
Status last verified: Jul 2024
First submitted: 28 Oct 2021
Last updated: 24 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Necrotizing Fascitis
Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
Recruiting
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Necrotizing Fascitis, Necrotizing Soft Tissue Infection
RecruitingPhase 4
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
Necrotizing Soft Tissue Infection
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction

All Necrotizing Soft Tissue Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial
ClinicalTrials.gov ID: NCT05157360
Acronym / sponsor ID: KUVC1814
Conditions: Necrotizing Soft Tissue Infection, Sepsis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow recruitment and not anticipated to meet recruitment numbers
Enrolment: 10 participants (actual)
Lead sponsor: Ascension HealthIndustry (pharma, biotech, devices)
Collaborators: University of Kansas
Study start: 10 Sep 2021 (actual)
Primary completion: 16 May 2023 (actual)
Study completion: 16 May 2023 (actual)
First posted: 15 Dec 2021 (actual)
Results: Posted 24 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Primary outcome:

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment Arm	Experimental	Drug: HATPatients 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: 1. 1.5 g vitamin C every 6 hours for 4 days or until ICU discharge 2. 50 mg hydrocortisone every 6 hours for 7 days or until ICU discharge (followed by a taper over 3 days) 3. 200 mg thiamine every 12 hours for 4 days or until ICU discharge In our study, due to the prolonged ICU course typical of most patients with NSTIs, it is not felt feasible to continue indefinitely "until ICU discharge." Thus, treatment will be continued for 4 to 7 days plus a 3 day taper (respectively) as above, with no plan for a longer duration of treatment.
Control Arm	Placebo comparator	Drug: PlaceboThe 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HATAlso: hydrocortisone, vitamin C, vitamin B1hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT	Drug	Treatment Arm
PlaceboAlso: NaCl 0.9%normal saline solution	Drug	Control Arm

Primary outcome

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

8 secondary outcomes

Duration of Vasopressor Therapy
Time frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
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, approximately 7 to 10 days.
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, approximately 7 to 10 days.
Change in Serum Procalcitonin (PCT) Over First 72 Hours
Time frame: 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, approximately 7 to 10 days.
Procalcitonin Clearance
Time frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.
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, approximately 7 to 10 days.
Wound Status at Time of Hospital Discharge: Open
Time frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.

Results and safety

Results posted to the registry on 24 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm	5	5
Control Arm	5	5

Primary outcome: Hospital Survival

Time frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.. Count of participants. Unit: Participants

Measure	Treatment Arm n = 5	Control Arm n = 5
Value	2	5

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of randomization until hospital discharge or death, whichever comes first. This time frame ranged from 7 to 10 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	0 of 5 (0%)	0 of 5 (0%)	3 of 5
Control Arm	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): Due to the small number of participants enrolled, the findings are observational only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Necrotizing Soft Tissue Infection

RecruitingObservational study
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
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Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
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The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
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Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
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Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Resch, M.D. principal investigator

Surgeon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HAT in people with Necrotizing Soft Tissue Infection and Sepsis, run by Ascension Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Survival (time frame: Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.