How biomarkers reflect the prognosis and treatment of necrotising soft tissue infections and the effects of hyperbaric oxygen therapy: the protocol of the prospective cohort PROTREAT study conducted at a tertiary hospital in Copenhagen, Denmark
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How biomarkers reflect the prognosis and treatment of necrotising soft tissue infections and the effects of hyperbaric oxygen therapy : the protocol of the prospective cohort PROTREAT study conducted at a tertiary hospital in Copenhagen, Denmark. / Polzik, Peter; Johansson, Pär I; Hyldegaard, Ole.
I: B M J Open, Bind 7, Nr. 10, e017805, 10.2017.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - How biomarkers reflect the prognosis and treatment of necrotising soft tissue infections and the effects of hyperbaric oxygen therapy
T2 - the protocol of the prospective cohort PROTREAT study conducted at a tertiary hospital in Copenhagen, Denmark
AU - Polzik, Peter
AU - Johansson, Pär I
AU - Hyldegaard, Ole
N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
PY - 2017/10
Y1 - 2017/10
N2 - 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).
AB - 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).
KW - Journal Article
U2 - 10.1136/bmjopen-2017-017805
DO - 10.1136/bmjopen-2017-017805
M3 - Journal article
C2 - 28982834
VL - 7
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 10
M1 - e017805
ER -
ID: 186083235