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Abstract
Introduction Not enough is known regarding the prognosis and treatment of necrotising soft tissue infections (NSTIs). Mortality has been shown to be 25%–35%, with survivors coping with amputations and prolonged rehabilitation. This study will evaluate soluble urokinase-type plasminogen activator receptor (suPAR) as a possible prognostic marker of NSTI severity and mortality, as well as whether hyperbaric oxygen therapy (HBOT) can modulate markers of endothelial damage during NSTI. We hypothesise that in patients with NSTI, suPAR can provide prognostic risk assessment on hospital admission and that HBOT can reduce the endothelial damage that these patients are exposed to.
Methods and analysis This is a prospective observational study. Biomarkers will be measured in 150 patients who have been diagnosed with NSTI. On admission, baseline blood samples will be obtained. Following surgery and HBOT, daily blood samples will be obtained in order to measure endothelial and prognostic biomarkers (soluble thrombomodulin, syndecan-1, sE-selectin, vascular endothelial (VE)-cadherin, protein C and suPAR levels). Clinical data will be acquired during the first 7 days of stay in the intensive care unit. The primary outcomes in studies I and II will be endothelial biomarker levels after HBOT, and in study III suPAR levels as a marker of disease prognosis and severity.
Ethics and dissemination The study has been approved by the Regional Scientific Ethical Committee of Copenhagen (H-16021845) and the Danish Data Protection Agency (RH-2016-199). Results will be presented at national and international conferences and published in peer-reviewed scientific journals.
Trial registration number ClinicalTrials.gov Identifier NCT03147352. (Pre-results)
- infectious diseases
- intensive care
- surgery
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Footnotes
Contributors PP and OH designed and wrote the research protocol. PP is responsible for the sample size calculations and statistical methods. PP is responsible for data acquisition. PIJ contributed to drafting the protocol. PIJ is responsible for the laboratory work in studies I and II.
Funding The INFECT project is supported by The European Seventh Framework Programme (grant number 305340).
Competing interests None declared.
Ethics approval The Regional Health Research Ethics Committee of Denmark.
Provenance and peer review Not commissioned; externally peer reviewed.