Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521368-37-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Københavns Universitet | OTHER |
| AZ Sint-Lucas Brugge | OTHER |
| Ziekenhuis Oost-Limburg | OTHER |
| University Hospital, Antwerp |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | standard of care (e.g. intensive care, surgery, antibiotics) |
|
| Standard of care + hyperbaric oxygen treatment | Experimental | standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30-day all-cause mortality post-randomization | 30-day post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 90-day all-cause mortality post-randomization | 90-day post-randomization |
| Amputations | Amputation (y/n) within 7 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionaire | Quality of life at Day 90 evaluated with the 5Q-5D-5L and WHO-DAS questionaire | 90 days post-randomization |
| Days alive and out of hospital | Days alive and out of hospital in the 90-day period |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerpen | Recruiting | Antwerp | Edegem | 2650 | Belgium |
Not provided
| Label | URL |
|---|---|
| Official trial website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| OTHER |
| Rigshospitalet, Denmark | OTHER |
| Oslo University Hospital | OTHER |
| Haukeland University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
| Karolinska University Hospital | OTHER |
Investigator-initiated, international, multicentre, superiority, randomized, open-label, clinical trial
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care (Investigator Choice) | Other | Standard of care (e.g. intensive care, surgery, antibiotics) |
|
| 7 days post-randomization |
| 90 days post-randomization |
| Ventilator-free days | Ventilator-free days within 7 days post-randomization | 7 days post-randomization |
| Renal-replacement therapy | Need for renal-replacement therapy (y/n) within 7 days | 7 days post-randomization |
| Safety - serious adverse events | Number of patients with one or more serious adverse events up to 24 hours after last treatment | 24 hours after last treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |