NCT05157360

HAT for the Treatment of Sepsis Associated With NASTI

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Ascension Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Necrotizing Soft Tissue Infection
• Sepsis

Interventions

Type	Name	Description
DRUG	HAT	hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT
DRUG	Placebo	normal saline solution

Timeline

• Start date: 2021-09-10
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2021-12-15
• Last updated: 2024-07-24
• Results posted: 2024-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study