Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries
NCT ID: NCT04693442
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
245 participants
OBSERVATIONAL
2016-11-18
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients
NCT06915974
Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission
NCT01965340
Presepsin Diagnostic Performance in Severe Burn Sepsis
NCT07060560
Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis
NCT04103281
The Predictive Value of Hepatocyte Growth Factor and Soluble Receptor s-Met in Sepsis
NCT03340649
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Burn patients
with the condition
taking of blood, urine and blood samples and objective scar assessment
blood, urine and skin tissue sampling \& scar assessment questionnaires
Control group
without the condition (blood sampling only for adults) and children undergoing general anaesthetic procedures that involve skin resections (blood sampling and excised skin)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
taking of blood, urine and blood samples and objective scar assessment
blood, urine and skin tissue sampling \& scar assessment questionnaires
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged 16 and over admitted with a ≥15% TBSA
* Patients presented within 24 hours of thermal injury
Exclusion Criteria
* Decision not to treat made on admission due to the severity of the injury
* Patients with chemical and deep electrical burns
* Premorbid conditions
* Active Malignancy
* Patients receiving glucocorticoid treatment
* Multiple limb amputations
* Patients with known long term infections (i.e., Hepatitis B \& C, Human Immune Deficiency \[HIV\])
1 Year
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Scar Free Foundation
UNKNOWN
University of Birmingham
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Naiem Moiemen
Burns and Plastics Consultant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Naiem Moiemen, Surgeon
Role: PRINCIPAL_INVESTIGATOR
The Scar Free Foundation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Farina JA Jr, Rosique MJ, Rosique RG. Curbing inflammation in burn patients. Int J Inflam. 2013;2013:715645. doi: 10.1155/2013/715645. Epub 2013 May 20.
Xiao W, Mindrinos MN, Seok J, Cuschieri J, Cuenca AG, Gao H, Hayden DL, Hennessy L, Moore EE, Minei JP, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Brownstein BH, Mason PH, Baker HV, Finnerty CC, Jeschke MG, Lopez MC, Klein MB, Gamelli RL, Gibran NS, Arnoldo B, Xu W, Zhang Y, Calvano SE, McDonald-Smith GP, Schoenfeld DA, Storey JD, Cobb JP, Warren HS, Moldawer LL, Herndon DN, Lowry SF, Maier RV, Davis RW, Tompkins RG; Inflammation and Host Response to Injury Large-Scale Collaborative Research Program. A genomic storm in critically injured humans. J Exp Med. 2011 Dec 19;208(13):2581-90. doi: 10.1084/jem.20111354. Epub 2011 Nov 21.
Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca.
Mann EA, Baun MM, Meininger JC, Wade CE. Comparison of mortality associated with sepsis in the burn, trauma, and general intensive care unit patient: a systematic review of the literature. Shock. 2012 Jan;37(1):4-16. doi: 10.1097/SHK.0b013e318237d6bf.
Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
Brinkmann V, Reichard U, Goosmann C, Fauler B, Uhlemann Y, Weiss DS, Weinrauch Y, Zychlinsky A. Neutrophil extracellular traps kill bacteria. Science. 2004 Mar 5;303(5663):1532-5. doi: 10.1126/science.1092385.
Mocsai A. Diverse novel functions of neutrophils in immunity, inflammation, and beyond. J Exp Med. 2013 Jul 1;210(7):1283-99. doi: 10.1084/jem.20122220.
Butler KL, Ambravaneswaran V, Agrawal N, Bilodeau M, Toner M, Tompkins RG, Fagan S, Irimia D. Burn injury reduces neutrophil directional migration speed in microfluidic devices. PLoS One. 2010 Jul 30;5(7):e11921. doi: 10.1371/journal.pone.0011921.
Arturson G. Neutrophil granulocyte functions in severely burned patients. Burns Incl Therm Inj. 1985 Jun;11(5):309-19. doi: 10.1016/0305-4179(85)90093-2.
Bjerknes R, Vindenes H, Laerum OD. Altered neutrophil functions in patients with large burns. Blood Cells. 1990;16(1):127-41; discussion 142-3.
Jones CN, Moore M, Dimisko L, Alexander A, Ibrahim A, Hassell BA, Warren HS, Tompkins RG, Fagan SP, Irimia D. Spontaneous neutrophil migration patterns during sepsis after major burns. PLoS One. 2014 Dec 9;9(12):e114509. doi: 10.1371/journal.pone.0114509. eCollection 2014.
The World Health Organisation. Burns [updated April 2014; cited 2015 06.10.2015]. Available from: http://www.who.int/mediacentre/factsheets/fs365/en/.
Campisi J. Aging, cellular senescence, and cancer. Annu Rev Physiol. 2013;75:685-705. doi: 10.1146/annurev-physiol-030212-183653. Epub 2012 Nov 8.
Tullie S, Asiri A, Acharjee A, Moiemen NS, Lord JM, Harrison P, Hazeldine J. Day One Cell-Free DNA Levels as an Objective Prognostic Marker of Mortality in Major Burns Patients. Cells. 2025 Jun 1;14(11):821. doi: 10.3390/cells14110821.
Hazeldine J, McGee KC, Al-Tarrah K, Hassouna T, Patel K, Imran R, Bishop JRB, Bamford A, Barnes D, Wilson Y, Harrison P, Lord JM, Moiemen NS. 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. BMJ Open. 2021 Oct 22;11(10):e052035. doi: 10.1136/bmjopen-2021-052035.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRAS Project ID 200366
Identifier Type: OTHER
Identifier Source: secondary_id
RRK5814
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.