Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).

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.

Conditions

• Necrotizing Soft Tissue Infection

Interventions

DRUG

Hyperbaric oxygen treatment

Patients will be randomized to either standard of care or standard of care + adjunctive sessions of HBO2 treatment consisting of 60-90 minutes (according to local protocols) 2.8ATA (284 kPa (≈18 m' seawater equivalent)) 100% oxygen breathing. The first session will be performed as soon as possible after randomization at the trial site, and at least within 12 hours from randomization. A minimum of three sessions will be performed within 48 hours after randomization. If the patient is considered clinical unstable after the initial three sessions (e.g. ongoing progression of the necrotising process or requiring intravenous blood pressure support in a dosage considered not related to sedation agents) additional sessions must be administered at a rate of one per approximately 24 hours, up to a maximum of five treatments. All sessions must be completed within a total timeframe of 96 hours from randomization.

OTHER

Standard of Care (Investigator Choice)

Standard of care (e.g. intensive care, surgery, antibiotics)

Sponsors & Collaborators

• Københavns Universitet

  collaborator OTHER

• AZ Sint-Lucas Brugge

  collaborator OTHER

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Karolinska University Hospital

  collaborator OTHER

• Ole Hyldegaard

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-04

Primary Completion

2033-04-30

Completion

2033-06-30

Countries

• Belgium
• Norway

Study Locations