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.
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)
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
Parallel
Hyperbaric oxygen treatment
DrugPatients 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.
Standard of Care (Investigator Choice)
Other interventionStandard of care (e.g. intensive care, surgery, antibiotics)
Mortality
30-day all-cause mortality post-randomization
Mortality
90-day all-cause mortality post-randomization
Amputations
Amputation (y/n) within 7 days post-randomization
Quality of life questionaire
Quality of life at Day 90 evaluated with the 5Q-5D-5L and WHO-DAS questionaire
Days alive and out of hospital
Days alive and out of hospital in the 90-day period
Ventilator-free days
Ventilator-free days within 7 days post-randomization
Renal-replacement therapy
Need for renal-replacement therapy (y/n) within 7 days
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Ole Hyldegaard
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Københavns Universitet
Collaborator
AZ Sint-Lucas Brugge
Collaborator
Ziekenhuis Oost-Limburg
Collaborator
University Hospital, Antwerp
Collaborator
Rigshospitalet, Denmark
Collaborator
Oslo University Hospital
Collaborator
Haukeland University Hospital
Collaborator
Turku University Hospital
Collaborator
Karolinska University Hospital
Collaborator
