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HAT for Sepsis

Phase 1 & 2

Waitlist Available

Led By Thomas Resch, M.D.

Research Sponsored by Ascension Via Christi Hospitals Wichita, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Necrotizing soft tissue infection by clinical diagnosis and requiring surgical treatment

Sepsis by clinical diagnosis and/or by Sepsis-3 criteria, with source attributed to the wound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.

Awards & highlights

Study Summary

This trial is testing whether a new therapy called HAT is effective in treating patients with a serious infection and sepsis.

Who is the study for?

This trial is for adults with sepsis and necrotizing soft tissue infections needing ICU care and surgery. It's not for those under 18, pregnant or breastfeeding women, prisoners, people with severe chronic diseases expected to live less than 30 days unrelated to sepsis, or anyone allergic to the study drugs. Participants must weigh over 40 kg and cannot be using high-dose vitamin C.Check my eligibility

What is being tested?

The trial tests HAT therapy (a combination of vitamin C, thiamine, and corticosteroids) against a placebo in patients with acute necrotizing soft tissue infections (NSTI) complicated by sepsis. The goal is to see if HAT improves patient outcomes compared to a non-active treatment.See study design

What are the potential side effects?

Possible side effects include reactions related to high doses of vitamins such as stomach upset or kidney stones in susceptible individuals. Corticosteroids can cause increased blood sugar levels, mood changes, insomnia, and higher infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe infection in my soft tissues that needs surgery.

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I have been diagnosed with sepsis originating from a wound.

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I am expected to be or am currently in intensive care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome is measured from date of admission to date of discharge or date of death, whichever comes first, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospital Survival

Secondary outcome measures

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)

Change in serum procalcitonin (PCT) over first 72 hours

Duration of vasopressor therapy

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment ArmExperimental Treatment1 Intervention

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: 1.5 g vitamin C every 6 hours for 4 days or until ICU discharge 50 mg hydrocortisone every 6 hours for 7 days or until ICU discharge (followed by a taper over 3 days) 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.

Group II: Control ArmPlacebo Group1 Intervention

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).

0 / 3Eligibility criteria met