Clinical trial NCT04693442: Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries
Official title: A Multi-centre, Prospective Study to Examine the Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burns
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Scar Free Foundation
name: University of Birmingham
First posted: 2021-01-05
Enrollment: 245
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be admitted to any Burn Centre participating in the study. This includes but not limited to:

Queen Elizabeth Hospital Birmingham; Birmingham Children's Hospital; Mid Essex NHS Trust, Broomfield Hospital, Chelmsford

The patients will be new burns patients presented within 24 hours of thermal injury. They will be identified by the admitting doctor from the Burns Team.

Brief summary: The study aims to validate neutrophil function, immature granulocyte and plasma free DNA levels as predictive diagnostic biomarkers of sepsis in burn patients. Inclusion criteria includes healthy volunteers, patients aged 5-15 years old with burns affecting 20% or less Total Body Surface Area (TBSA) and patients aged 16 or above with burns affecting \>15% TBSA. The study involves taking blood, tissue and urine samples.

Detailed description: The initial cohort for SIFTI-2 will be generated from patients attending the Birmingham Burns Centre at Queen Elizabeth Hospital Birmingham (QEHB) and Birmingham Children's Hospital (BCH). The cohort will be comprised of patients with moderate and severe burns (injury to more than 15% of the body surface area \[TBSA\] in adults and 20% TBSA in children). The investigators currently treat between 30-40 patients in this category each year. In order to thoroughly characterise the longitudinal neutrophil response to burn injury and to investigate its potential relationship with outcome post-burn, the ivestigators will measure the genomic, phenotypic and functional response of peripheral blood neutrophils across time in burn-injured patients.

Eligibility criteria: Inclusion Criteria:

* Patients aged 1-15 years admitted with a ≥20%TBSA
* Patients aged 16 and over admitted with a ≥15% TBSA
* Patients presented within 24 hours of thermal injury

Exclusion Criteria:

* Associated multiple injuries with Injury severity score \> 25
* 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 \[HIV\])

Primary outcomes:
measure: Diagnosis of sepsis
timeFrame: 2 years
Secondary outcomes:
measure: In-hospital mortality
timeFrame: 2 years
measure: Predictive mortality scores
timeFrame: 2 years
measure: Multiple Organ Failure/dysfunction syndrome (MOF/MODS)
timeFrame: 2 years
measure: Thromboembolic complications
timeFrame: 2 years
measure: Vancouver Scar Scale (VSS)
timeFrame: 2 years
measure: Patient and Observer Scar Assessment Scale
timeFrame: 2 years
measure: Brisbane Burn Scar Impact Profile
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
Study officials:
affiliation: The Scar Free Foundation
name: Naiem Moiemen, Surgeon
role: PRINCIPAL_INVESTIGATOR
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