Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Ole Hyldegaard
- Enrollment
- 1,480
- Primary Endpoint
- Mortality
Overview
Brief Summary
Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists.
The primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (age ≥18 years)
- •Surgical confirmed NSTI (defined by perioperative tissue characteristics observed by the surgeon. The diagnosis is based on sign as necrotic or deliquescent soft tissue with widespread undermining of the surrounding tissue)
Exclusion Criteria
- •Contraindications for HBO2 treatment according to local protocol (e.g., undrained pneumothorax)
- •Confirmed pregnancy
- •Referred to palliative care
- •Previously randomized into the HOT-NSTI trial
- •Known objection by the patient to participate in the trial
- •Allergy against study drug
Outcomes
Primary Outcomes
Mortality
Time Frame: 30-day post-randomization
30-day all-cause mortality post-randomization
Secondary Outcomes
- Mortality(90-day post-randomization)
- Amputations(7 days post-randomization)
Investigators
Ole Hyldegaard
Professor, MD, Ph.D., DMSci
Rigshospitalet, Denmark