PMID- 25967993
OWN - NLM
STAT- MEDLINE
DCOM- 20160301
LR  - 20190202
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 5
IP  - 5
DP  - 2015 May 11
TI  - Biomarkers of necrotising soft tissue infections: aspects of the innate immune 
      response and effects of hyperbaric oxygenation-the protocol of the prospective 
      cohort BIONEC study.
PG  - e006995
LID - 10.1136/bmjopen-2014-006995 [doi]
LID - e006995
AB  - INTRODUCTION: The mortality and amputation rates are still high in patients with 
      necrotising soft tissue infections (NSTIs). It would be ideal to have a set of 
      biomarkers that enables the clinician to identify high-risk patients with NSTI on 
      admission. The objectives of this study are to evaluate inflammatory and 
      vasoactive biomarkers as prognostic markers of severity and mortality in patients 
      with NSTI and to investigate whether hyperbaric oxygen treatment (HBOT) is able 
      to modulate these biomarkers. The overall hypothesis is that plasma biomarkers 
      can be used as prognostic markers of severity and mortality in patients with NSTI 
      and that HBOT reduces the inflammatory response. METHODS AND ANALYSIS: This is a 
      prospective, observational study being conducted in a tertiary referral centre. 
      Biomarkers will be measured in 114 patients who have been operatively diagnosed 
      with NSTI. On admission, baseline blood values will be obtained. Following 
      surgery and HBOT, daily blood samples for measuring regular inflammatory and 
      vasoactive biomarkers (pentraxin-3, interleukin-6 and nitrite) will be acquired. 
      Samples will be analysed using validated ELISA assays, chemiluminescence and 
      Griess reaction. Clinical data will be obtained during admission in the intensive 
      care unit for a maximum of 7 days. The primary analysis will focus on 
      pentraxin-3, interleukin-6 and nitrite as early markers of disease severity in 
      patients with NSTI. ETHICS AND DISSEMINATION: The study has been approved by the 
      Regional Scientific Ethical Committee of Copenhagen (H-2-2014-071) and the Danish 
      Data Protection Agency (J. no. 30-0900 and J. no. 30-1282). Results will be 
      presented at national and international conferences and published in 
      peer-reviewed scientific journals. TRIAL REGISTRATION: NCT02180906.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://group.bmj.com/group/rights-licensing/permissions.
FAU - Hansen, Marco Bo
AU  - Hansen MB
AD  - Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University 
      Hospital, Rigshospitalet, Denmark.
FAU - Simonsen, Ulf
AU  - Simonsen U
AD  - Department of Biomedicine, Pulmonary and Cardiovascular Pharmacology, University 
      of Aarhus, Aarhus, Denmark.
FAU - Garred, Peter
AU  - Garred P
AD  - Laboratory of Molecular Medicine, Department of Clinical Immunology, Copenhagen 
      University Hospital, Rigshospitalet, Denmark.
FAU - Hyldegaard, Ole
AU  - Hyldegaard O
AD  - Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University 
      Hospital, Rigshospitalet, Denmark.
LA  - eng
SI  - ClinicalTrials.gov/NCT02180906
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150511
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Biomarkers)
RN  - 0 (IL6 protein, human)
RN  - 0 (Interleukin-6)
RN  - 0 (Nitrites)
RN  - 0 (Serum Amyloid P-Component)
RN  - 148591-49-5 (PTX3 protein)
RN  - 9007-41-4 (C-Reactive Protein)
SB  - IM
MH  - Biomarkers/blood
MH  - C-Reactive Protein/*metabolism
MH  - Critical Care
MH  - Fasciitis, Necrotizing/blood/*immunology
MH  - Female
MH  - Humans
MH  - Hyperbaric Oxygenation/*methods
MH  - Immunity, Innate/*immunology
MH  - Interleukin-6/*blood
MH  - Length of Stay
MH  - Male
MH  - Nitrites/*blood
MH  - Prognosis
MH  - Prospective Studies
MH  - Serum Amyloid P-Component/*metabolism
MH  - Soft Tissue Infections/blood/*immunology
MH  - Treatment Outcome
PMC - PMC4431132
OTO - NOTNLM
OT  - BACTERIOLOGY
OT  - IMMUNOLOGY
EDAT- 2015/05/15 06:00
MHDA- 2016/03/02 06:00
PMCR- 2015/05/11
CRDT- 2015/05/14 06:00
PHST- 2015/05/14 06:00 [entrez]
PHST- 2015/05/15 06:00 [pubmed]
PHST- 2016/03/02 06:00 [medline]
PHST- 2015/05/11 00:00 [pmc-release]
AID - bmjopen-2014-006995 [pii]
AID - 10.1136/bmjopen-2014-006995 [doi]
PST - epublish
SO  - BMJ Open. 2015 May 11;5(5):e006995. doi: 10.1136/bmjopen-2014-006995.