Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
Ascension Via Christi Hospital - St. Francis Campus
Wichita, Kansas, United States
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.
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.
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.
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)
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).
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)
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.
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
This is a binary variable that will show whether there was a decrease in serum procalcitonin (PCT) over first 72 hours.
Time frame: Over the first 72 hours from admission.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
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
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
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
This is a variable that will show the count of wound related surgeries during the time the patient is admitted to the hospital.
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
This shows the number of participants with an open wound at time of hospital discharge.
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.