Cargando…

Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study

INTRODUCTION: Burn-induced changes in the phenotype and function of neutrophils, cells which provide front-line protection against rapidly dividing bacterial infections, are emerging as potential biomarkers for the early prediction of sepsis. In a longitudinal study of adult burns patients, we recen...

Descripción completa

Detalles Bibliográficos
Autores principales: Hazeldine, Jon, McGee, Kirsty C, Al-Tarrah, Khaled, Hassouna, Tarek, Patel, Krupali, Imran, Rizwana, Bishop, Jonathan R B, Bamford, Amy, Barnes, David, Wilson, Yvonne, Harrison, Paul, Lord, Janet M, Moiemen, Naiem S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8543641/
https://www.ncbi.nlm.nih.gov/pubmed/34686556
http://dx.doi.org/10.1136/bmjopen-2021-052035
_version_ 1784589662767022080
author Hazeldine, Jon
McGee, Kirsty C
Al-Tarrah, Khaled
Hassouna, Tarek
Patel, Krupali
Imran, Rizwana
Bishop, Jonathan R B
Bamford, Amy
Barnes, David
Wilson, Yvonne
Harrison, Paul
Lord, Janet M
Moiemen, Naiem S
author_facet Hazeldine, Jon
McGee, Kirsty C
Al-Tarrah, Khaled
Hassouna, Tarek
Patel, Krupali
Imran, Rizwana
Bishop, Jonathan R B
Bamford, Amy
Barnes, David
Wilson, Yvonne
Harrison, Paul
Lord, Janet M
Moiemen, Naiem S
author_sort Hazeldine, Jon
collection PubMed
description INTRODUCTION: Burn-induced changes in the phenotype and function of neutrophils, cells which provide front-line protection against rapidly dividing bacterial infections, are emerging as potential biomarkers for the early prediction of sepsis. In a longitudinal study of adult burns patients, we recently demonstrated that a combined measurement of neutrophil phagocytic capacity, immature granulocyte (IG) count and plasma cell-free DNA (cfDNA) levels on the day of injury gave good discriminatory power for the prediction of later sepsis development. However, limited by a small sample size, single-centre design and focus on adult burns patients, these biomarkers require prospective validation in a larger patient cohort. The Scientific Investigation of the Biological Pathways Following Thermal Injury-2 study aims to prospectively validate neutrophil phagocytic activity, IG count and plasma cfDNA levels as early prognostic biomarkers of sepsis in thermally injured adult and paediatric patients. METHODS AND ANALYSIS: This multicentre, longitudinal, observational cohort study will enrol 245 paediatric and adult patients with moderate to severe burns within 24 hours of injury. Blood samples will be obtained at 19 postinjury time points (days 1–14, day 28, months 3, 6, 12 and 24) and analysed for neutrophil phagocytic activity, IG count and cfDNA levels. Patients will be screened daily for sepsis using the 2007 American Burn Association diagnostic criteria for sepsis. In addition, daily multiple organ dysfunction syndrome and Sequential Organ Failure Assessment Scores will be recorded relationships between neutrophil phagocytic activity, IG count and plasma cfDNA levels on day 1 of injury and the development of sepsis will be examined using logistic regression models. ETHICS AND DISSEMINATION: This study received ethics approval from the West Midlands, Coventry and Warwickshire Research Ethics Committee (REC reference:16/WM/0217). Findings will be presented at national and international conferences, and submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04693442.
format Online
Article
Text
id pubmed-8543641
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-85436412021-11-10 Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study Hazeldine, Jon McGee, Kirsty C Al-Tarrah, Khaled Hassouna, Tarek Patel, Krupali Imran, Rizwana Bishop, Jonathan R B Bamford, Amy Barnes, David Wilson, Yvonne Harrison, Paul Lord, Janet M Moiemen, Naiem S BMJ Open Intensive Care INTRODUCTION: Burn-induced changes in the phenotype and function of neutrophils, cells which provide front-line protection against rapidly dividing bacterial infections, are emerging as potential biomarkers for the early prediction of sepsis. In a longitudinal study of adult burns patients, we recently demonstrated that a combined measurement of neutrophil phagocytic capacity, immature granulocyte (IG) count and plasma cell-free DNA (cfDNA) levels on the day of injury gave good discriminatory power for the prediction of later sepsis development. However, limited by a small sample size, single-centre design and focus on adult burns patients, these biomarkers require prospective validation in a larger patient cohort. The Scientific Investigation of the Biological Pathways Following Thermal Injury-2 study aims to prospectively validate neutrophil phagocytic activity, IG count and plasma cfDNA levels as early prognostic biomarkers of sepsis in thermally injured adult and paediatric patients. METHODS AND ANALYSIS: This multicentre, longitudinal, observational cohort study will enrol 245 paediatric and adult patients with moderate to severe burns within 24 hours of injury. Blood samples will be obtained at 19 postinjury time points (days 1–14, day 28, months 3, 6, 12 and 24) and analysed for neutrophil phagocytic activity, IG count and cfDNA levels. Patients will be screened daily for sepsis using the 2007 American Burn Association diagnostic criteria for sepsis. In addition, daily multiple organ dysfunction syndrome and Sequential Organ Failure Assessment Scores will be recorded relationships between neutrophil phagocytic activity, IG count and plasma cfDNA levels on day 1 of injury and the development of sepsis will be examined using logistic regression models. ETHICS AND DISSEMINATION: This study received ethics approval from the West Midlands, Coventry and Warwickshire Research Ethics Committee (REC reference:16/WM/0217). Findings will be presented at national and international conferences, and submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04693442. BMJ Publishing Group 2021-10-22 /pmc/articles/PMC8543641/ /pubmed/34686556 http://dx.doi.org/10.1136/bmjopen-2021-052035 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Intensive Care
Hazeldine, Jon
McGee, Kirsty C
Al-Tarrah, Khaled
Hassouna, Tarek
Patel, Krupali
Imran, Rizwana
Bishop, Jonathan R B
Bamford, Amy
Barnes, David
Wilson, Yvonne
Harrison, Paul
Lord, Janet M
Moiemen, Naiem S
Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study
title Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study
title_full Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study
title_fullStr Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study
title_full_unstemmed Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study
title_short Multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the Scientific Investigation of the Biological Pathways Following Thermal Injury-2 (SIFTI-2) study
title_sort multicentre, longitudinal, observational cohort study to examine the relationship between neutrophil function and sepsis in adults and children with severe thermal injuries: a protocol for the scientific investigation of the biological pathways following thermal injury-2 (sifti-2) study
topic Intensive Care
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8543641/
https://www.ncbi.nlm.nih.gov/pubmed/34686556
http://dx.doi.org/10.1136/bmjopen-2021-052035
work_keys_str_mv AT hazeldinejon multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT mcgeekirstyc multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT altarrahkhaled multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT hassounatarek multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT patelkrupali multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT imranrizwana multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT bishopjonathanrb multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT bamfordamy multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT barnesdavid multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT wilsonyvonne multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT harrisonpaul multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT lordjanetm multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study
AT moiemennaiems multicentrelongitudinalobservationalcohortstudytoexaminetherelationshipbetweenneutrophilfunctionandsepsisinadultsandchildrenwithseverethermalinjuriesaprotocolforthescientificinvestigationofthebiologicalpathwaysfollowingthermalinjury2sifti2study