Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries (SIFTI-2)

University Hospital Birmingham NHS Foundation Trust

Status: Unknown

Conditions: Burns

Treatments: Other: taking of blood, urine and blood samples and objective scar assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04693442

IRAS Project ID 200366 (Other Identifier)

RRK5814

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 estimated patients

Sex: All

Ages: 1 to 99 years old

Volunteers: Accepts Healthy Volunteers

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])

Trial design

245 participants in 2 patient groups

Burn patients

Description:

with the condition

Treatment:

Other: taking of blood, urine and blood samples and objective scar assessment

Control group

Description:

without the condition (blood sampling only for adults) and children undergoing general anaesthetic procedures that involve skin resections (blood sampling and excised skin)