A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study

BACKGROUND:. Sepsis is a common and deadly syndrome, accounting for more than 11 million deaths annually. To mature a deeper understanding of the host and pathogen mechanisms contributing to poor outcomes in sepsis, and thereby possibly inform new therapeutic targets, sophisticated, and expensive bi...

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Main Authors: Christopher W. Seymour, MD, MSc, Kelly Lynn Urbanek, MS, Anna Nakayama, Jason N. Kennedy, MS, Rachel Powell, MD, Renã A.S. Robinson, PhD, Kathryn L. Kapp, BS, Timothy R. Billiar, MD, Yoram Vodovotz, PhD, Stacy L. Gelhaus, PhD, Vaughn S. Cooper, PhD, Lu Tang, PhD, Flo Mayr, MD, Katherine M. Reitz, MD, MSc, Christopher Horvat, MD, Nuala J. Meyer, MD, MS, Robert P. Dickson, Derek Angus, MD, Octavia Peck Palmer, PhD
Format: Article
Language:English
Published: Wolters Kluwer 2023-11-01
Series:Critical Care Explorations
Online Access:http://journals.lww.com/10.1097/CCE.0000000000000974
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author Christopher W. Seymour, MD, MSc
Kelly Lynn Urbanek, MS
Anna Nakayama
Jason N. Kennedy, MS
Rachel Powell, MD
Renã A.S. Robinson, PhD
Kathryn L. Kapp, BS
Timothy R. Billiar, MD
Yoram Vodovotz, PhD
Stacy L. Gelhaus, PhD
Vaughn S. Cooper, PhD
Lu Tang, PhD
Flo Mayr, MD
Katherine M. Reitz, MD, MSc
Christopher Horvat, MD
Nuala J. Meyer, MD, MS
Robert P. Dickson
Derek Angus, MD
Octavia Peck Palmer, PhD
author_facet Christopher W. Seymour, MD, MSc
Kelly Lynn Urbanek, MS
Anna Nakayama
Jason N. Kennedy, MS
Rachel Powell, MD
Renã A.S. Robinson, PhD
Kathryn L. Kapp, BS
Timothy R. Billiar, MD
Yoram Vodovotz, PhD
Stacy L. Gelhaus, PhD
Vaughn S. Cooper, PhD
Lu Tang, PhD
Flo Mayr, MD
Katherine M. Reitz, MD, MSc
Christopher Horvat, MD
Nuala J. Meyer, MD, MS
Robert P. Dickson
Derek Angus, MD
Octavia Peck Palmer, PhD
author_sort Christopher W. Seymour, MD, MSc
collection DOAJ
description BACKGROUND:. Sepsis is a common and deadly syndrome, accounting for more than 11 million deaths annually. To mature a deeper understanding of the host and pathogen mechanisms contributing to poor outcomes in sepsis, and thereby possibly inform new therapeutic targets, sophisticated, and expensive biorepositories are typically required. We propose that remnant biospecimens are an alternative for mechanistic sepsis research, although the viability and scientific value of such remnants are unknown. METHODS AND RESULTS:. The Remnant Biospecimen Investigation in Sepsis study is a prospective cohort study of 225 adults (age ≥ 18 yr) presenting to the emergency department with community sepsis, defined as sepsis-3 criteria within 6 hours of arrival. The primary objective was to determine the scientific value of a remnant biospecimen repository in sepsis linked to clinical phenotyping in the electronic health record. We will study candidate multiomic readouts of sepsis biology, governed by a conceptual model, and determine the precision, accuracy, integrity, and comparability of proteins, small molecules, lipids, and pathogen sequencing in remnant biospecimens compared with paired biospecimens obtained according to research protocols. Paired biospecimens will include plasma from sodium–heparin, EDTA, sodium fluoride, and citrate tubes. CONCLUSIONS:. The study has received approval from the University of Pittsburgh Human Research Protection Office (Study 21120013). Recruitment began on October 25, 2022, with planned release of primary results anticipated in 2024. Results will be made available to the public, the funders, critical care societies, laboratory medicine scientists, and other researchers.
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spelling doaj.art-7ed111b6ecb34b9ea933120437ef97002024-02-28T06:47:13ZengWolters KluwerCritical Care Explorations2639-80282023-11-01511e097410.1097/CCE.0000000000000974202311000-00005A Prospective Cohort Protocol for the Remnant Investigation in Sepsis StudyChristopher W. Seymour, MD, MSc0Kelly Lynn Urbanek, MS1Anna Nakayama2Jason N. Kennedy, MS3Rachel Powell, MD4Renã A.S. Robinson, PhD5Kathryn L. Kapp, BS6Timothy R. Billiar, MD7Yoram Vodovotz, PhD8Stacy L. Gelhaus, PhD9Vaughn S. Cooper, PhD10Lu Tang, PhD11Flo Mayr, MD12Katherine M. Reitz, MD, MSc13Christopher Horvat, MD14Nuala J. Meyer, MD, MS15Robert P. Dickson16Derek Angus, MD17Octavia Peck Palmer, PhD181 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA4 Department of Chemistry, Vanderbilt University, Nashville, TN.4 Department of Chemistry, Vanderbilt University, Nashville, TN.5 Department of Surgery, UPMC, Pittsburgh, PA.5 Department of Surgery, UPMC, Pittsburgh, PA.6 Department of Pharmacology and Chemical Biology, University of Pittsburgh School of Medicine, Pittsburgh, PA.7 Department of Microbiology and Molecular Genetics, University of Pittsburgh School of Medicine, Pittsburgh, PA.8 Department of Biostatistics, University of Pittsburgh School of Public Health, Pittsburgh, PA.1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA2 Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA9 Pulmonary, Allergy, and Critical Care Medicine Division, Center for Translational Lung Biology University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.10 Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, MI.1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA1 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PABACKGROUND:. Sepsis is a common and deadly syndrome, accounting for more than 11 million deaths annually. To mature a deeper understanding of the host and pathogen mechanisms contributing to poor outcomes in sepsis, and thereby possibly inform new therapeutic targets, sophisticated, and expensive biorepositories are typically required. We propose that remnant biospecimens are an alternative for mechanistic sepsis research, although the viability and scientific value of such remnants are unknown. METHODS AND RESULTS:. The Remnant Biospecimen Investigation in Sepsis study is a prospective cohort study of 225 adults (age ≥ 18 yr) presenting to the emergency department with community sepsis, defined as sepsis-3 criteria within 6 hours of arrival. The primary objective was to determine the scientific value of a remnant biospecimen repository in sepsis linked to clinical phenotyping in the electronic health record. We will study candidate multiomic readouts of sepsis biology, governed by a conceptual model, and determine the precision, accuracy, integrity, and comparability of proteins, small molecules, lipids, and pathogen sequencing in remnant biospecimens compared with paired biospecimens obtained according to research protocols. Paired biospecimens will include plasma from sodium–heparin, EDTA, sodium fluoride, and citrate tubes. CONCLUSIONS:. The study has received approval from the University of Pittsburgh Human Research Protection Office (Study 21120013). Recruitment began on October 25, 2022, with planned release of primary results anticipated in 2024. Results will be made available to the public, the funders, critical care societies, laboratory medicine scientists, and other researchers.http://journals.lww.com/10.1097/CCE.0000000000000974
spellingShingle Christopher W. Seymour, MD, MSc
Kelly Lynn Urbanek, MS
Anna Nakayama
Jason N. Kennedy, MS
Rachel Powell, MD
Renã A.S. Robinson, PhD
Kathryn L. Kapp, BS
Timothy R. Billiar, MD
Yoram Vodovotz, PhD
Stacy L. Gelhaus, PhD
Vaughn S. Cooper, PhD
Lu Tang, PhD
Flo Mayr, MD
Katherine M. Reitz, MD, MSc
Christopher Horvat, MD
Nuala J. Meyer, MD, MS
Robert P. Dickson
Derek Angus, MD
Octavia Peck Palmer, PhD
A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study
Critical Care Explorations
title A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study
title_full A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study
title_fullStr A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study
title_full_unstemmed A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study
title_short A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study
title_sort prospective cohort protocol for the remnant investigation in sepsis study
url http://journals.lww.com/10.1097/CCE.0000000000000974
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