Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT05157360
Status:
TERMINATED
Last Update Posted:
2024-07-24
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HAT for the Treatment of Sepsis Associated With NASTI
Sponsor:
Ascension Via Christi Hospitals Wichita, Inc.
Organization:
Study Overview
Official Title:
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment and not anticipated to meet recruitment numbers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis.
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: