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Adjunctive Hyperbaric Oxygen Treatment for Patients with Necrotizing Soft-Tissue Infection (HOT-NSTI trial)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521368-37-00
Enrollment
980
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing soft-tissue infection

Brief summary

30-day all-cause mortality post-randomization

Detailed description

90-day all-cause mortality post-randomization, Amputation (y/n) within 7 days post-randomization, Quality of life at Day 90 evaluated with the 5Q-5D-5L, Quality of life at Day 90 evaluated with the WHO-DAS questionnaire, Days alive and out of hospital in the 90-day period, Ventilator-free days within 7 days post-randomization, Need for renal-replacement therapy (y/n) within 7 days, Number of subjects with one or more serious adverse events up to 24 hours after last treatment

Interventions

DRUGMedical Liquid Oxygen

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality post-randomization

Secondary

MeasureTime frame
90-day all-cause mortality post-randomization, Amputation (y/n) within 7 days post-randomization, Quality of life at Day 90 evaluated with the 5Q-5D-5L, Quality of life at Day 90 evaluated with the WHO-DAS questionnaire, Days alive and out of hospital in the 90-day period, Ventilator-free days within 7 days post-randomization, Need for renal-replacement therapy (y/n) within 7 days, Number of subjects with one or more serious adverse events up to 24 hours after last treatment

Countries

Belgium, Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026