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slow recruitment and not anticipated to meet recruitment numbers
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| Name | Class |
|---|---|
| University of Kansas | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAT | Drug | hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, approximately 7 to 10 days. |
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Inclusion Criteria:
Exclusion Criteria: (Adapted from Sevransky et. al's VICTAS protocol)
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Resch, M.D. | Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Via Christi Hospital - St. Francis Campus | Wichita | Kansas | 67214 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
HAT: hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT |
| FG001 | 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). Placebo: normal saline solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
HAT: hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
From time of randomization until hospital discharge or death, whichever comes first. This time frame ranged from 7 to 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
HAT: hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT |
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Due to the small number of participants enrolled, the findings are observational only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Resch | Department of Surgery, University of Kansas School of Medicine-Wichita | 316-268-5990 | tresch@wsspa.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2024 | May 7, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2021 | Sep 7, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D001205 | Ascorbic Acid |
| D013831 | Thiamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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A randomization list will be used to show whether patients will be in group A or B. Only the Research Scientist who made the randomization list and the Pharmacy will know what group patients are in. The Burn Program Coordinator will get consent and enroll patients to the study. After that, the Burn Program Coordinator will call the pharmacy and report what group the patient is enrolled in, A or B. Then, the pharmacy will order the respective medications.
The doctors and nurses providing care for the patients will not know who is in what treatment group, and neither will the patients.
| Placebo | Drug | normal saline solution |
|
|
| 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, 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. | 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. | 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). | 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 | 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. | 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. | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
| BG001 | 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). Placebo: normal saline solution |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). Placebo: normal saline solution |
|
|
| 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. | Posted | Median | Inter-Quartile Range | hours | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| 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). | Posted | Count of Participants | Participants | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | days | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 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 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). | Posted | Count of Participants | Participants | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| Secondary | 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 | Posted | Mean | Full Range | percentage of decrease in procalcitonin | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Wound related surgeries | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| Secondary | Wound Status at Time of Hospital Discharge: Open | This shows the number of participants with an open wound at time of hospital discharge. | Posted | Count of Participants | Participants | Outcome is measured from date of admission to date of discharge or date of death, whichever comes first, approximately 7 to 10 days. |
|
|
|
| 3 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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). Placebo: normal saline solution | 0 | 5 | 0 | 5 | 0 | 5 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |