Investigating the Effects of Hyperbaric Oxygen Treatment in Necrotizing Soft Tissue Infection With Transcriptomics and Machine Learning (the HBOmic Study): Protocol for a Prospective Cohort Study With Data Validation
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Investigating the Effects of Hyperbaric Oxygen Treatment in Necrotizing Soft Tissue Infection With Transcriptomics and Machine Learning (the HBOmic Study) : Protocol for a Prospective Cohort Study With Data Validation. / Vinkel, Julie; Rib, Leonor; Buil, Alfonso; Hedetoft, Morten; Hyldegaard, Ole.
I: JMIR Research Protocols, Bind 11, Nr. 11, e39252, 2022.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Investigating the Effects of Hyperbaric Oxygen Treatment in Necrotizing Soft Tissue Infection With Transcriptomics and Machine Learning (the HBOmic Study)
T2 - Protocol for a Prospective Cohort Study With Data Validation
AU - Vinkel, Julie
AU - Rib, Leonor
AU - Buil, Alfonso
AU - Hedetoft, Morten
AU - Hyldegaard, Ole
N1 - Publisher Copyright: ©Julie Vinkel, Leonor Rib, Alfonso Buil, Morten Hedetoft, Ole Hyldegaard.
PY - 2022
Y1 - 2022
N2 - Background: Necrotizing soft tissue infections (NSTIs) are complex multifactorial diseases characterized by rapid bacterial proliferation and progressive tissue death. Treatment is multidisciplinary, including surgery, broad-spectrum antibiotics, and intensive care; adjunctive treatment with hyperbaric oxygen (HBO2) may also be applied. Recent advances in molecular technology and biological computation have given rise to new approaches to infectious diseases based on identifying target groups defined by activated pathophysiological mechanisms. Objective: We aim to capture NSTI disease signatures and mechanisms and responses to treatment in patients that receive the highest standard of care; therefore, we set out to investigate genome-wide transcriptional responses to HBO2 treatment during NSTI in the host and bacteria. Methods: The Effects of Hyperbaric Oxygen Treatment Studied with Omics (HBOmic) study is a prospective cohort study including 95 patients admitted for NSTI at the intensive care unit of Copenhagen University Hospital (Rigshospitalet), Denmark, between January 2013 and June 2017. All participants were treated according to a local protocol for management of NSTI, and biological samples were obtained and stored according to a standard operational procedure. In the proposed study, we will generate genome-wide expression profiles of whole-blood samples and samples of infected tissue taken before and after HBO2 treatment administered during the initial acute phase of infection, and we will analyze the profiles with unsupervised hierarchical clustering and machine learning. Differential gene expression will be compared in samples taken before and after HBO2 treatment (N=85), and integration of profiles from blood and tissue samples will be performed. Furthermore, findings will be compared to NSTI patients who did not receive HBO2 treatment (N=10). Transcriptomic data will be integrated with clinical data to investigate associations and predictors. Results: The first participant was enrolled on July 27, 2021, and data analysis is expected to begin during autumn 2022, with publication of results immediately thereafter. Conclusions: The HBOmic study will provide new insights into personalized patient management in NSTIs. Trial Registration: ClinicalTrials.gov NCT01790698; https://clinicaltrials.gov/ct2/show/NCT01790698 International Registered Report Identifier (IRRID): DERR1-10.2196/39252
AB - Background: Necrotizing soft tissue infections (NSTIs) are complex multifactorial diseases characterized by rapid bacterial proliferation and progressive tissue death. Treatment is multidisciplinary, including surgery, broad-spectrum antibiotics, and intensive care; adjunctive treatment with hyperbaric oxygen (HBO2) may also be applied. Recent advances in molecular technology and biological computation have given rise to new approaches to infectious diseases based on identifying target groups defined by activated pathophysiological mechanisms. Objective: We aim to capture NSTI disease signatures and mechanisms and responses to treatment in patients that receive the highest standard of care; therefore, we set out to investigate genome-wide transcriptional responses to HBO2 treatment during NSTI in the host and bacteria. Methods: The Effects of Hyperbaric Oxygen Treatment Studied with Omics (HBOmic) study is a prospective cohort study including 95 patients admitted for NSTI at the intensive care unit of Copenhagen University Hospital (Rigshospitalet), Denmark, between January 2013 and June 2017. All participants were treated according to a local protocol for management of NSTI, and biological samples were obtained and stored according to a standard operational procedure. In the proposed study, we will generate genome-wide expression profiles of whole-blood samples and samples of infected tissue taken before and after HBO2 treatment administered during the initial acute phase of infection, and we will analyze the profiles with unsupervised hierarchical clustering and machine learning. Differential gene expression will be compared in samples taken before and after HBO2 treatment (N=85), and integration of profiles from blood and tissue samples will be performed. Furthermore, findings will be compared to NSTI patients who did not receive HBO2 treatment (N=10). Transcriptomic data will be integrated with clinical data to investigate associations and predictors. Results: The first participant was enrolled on July 27, 2021, and data analysis is expected to begin during autumn 2022, with publication of results immediately thereafter. Conclusions: The HBOmic study will provide new insights into personalized patient management in NSTIs. Trial Registration: ClinicalTrials.gov NCT01790698; https://clinicaltrials.gov/ct2/show/NCT01790698 International Registered Report Identifier (IRRID): DERR1-10.2196/39252
KW - biomarker
KW - data
KW - genome
KW - host-pathogen interaction
KW - hyperbaric oxygen treatment
KW - immune system
KW - immunology
KW - infection
KW - longitudinal
KW - machine learning
KW - mechanism
KW - necrotizing soft tissue infection
KW - NSTI
KW - oxygen
KW - response
KW - sepsis
KW - signaling
KW - soft tissue infection
KW - study protocol
KW - tissue
KW - transcriptomic
KW - treatment
KW - validation
U2 - 10.2196/39252
DO - 10.2196/39252
M3 - Journal article
C2 - 36427229
AN - SCOPUS:85144793688
VL - 11
JO - J M I R Research Protocols
JF - J M I R Research Protocols
SN - 1929-0748
IS - 11
M1 - e39252
ER -
ID: 340552258