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

December 30, 2020 updated by: Naiem Moiemen, University Hospital Birmingham NHS Foundation Trust

A Multi-centre, Prospective Study to Examine the Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Burn patients
with the condition
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of sepsis
Time Frame: 2 years

Sepsis will be evaluated according to the 2007 American Burn Association (ABA) diagnostic criteria for sepsis in burns. Specifically, sepsis will be diagnosed when 3 of the following criteria are met along with a positive bacterial culture or when evidence of a clinical response to antibiotics is detected:

  1. Temperature (>39°C or <36°C)
  2. progressive tachycardia (>110 beats per minute
  3. progressive tachypnea (>25 breaths per minute not ventilated or minute ventilation >12 L/minute ventilated)
  4. thrombocytopenia (<100,000/μl; not applied until 3 days after initial resuscitation)
  5. hyperglycaemia (untreated plasma glucose >200 mg/dl, >7 units of insulin/hr intravenous drip, or >25% increase in insulin requirements over 24 hours)
  6. feed intolerance >24 hours (abdominal distension, residuals two times the feeding rate, or diarrhoea >2500 ml/day)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 2 years
Death while in-hospital
2 years
Predictive mortality scores
Time Frame: 2 years
Predictive mortality scores are measured by Revised Baux Score, Abbreviated Burn Severity Index (ABSI), and APACHE II
2 years
Multiple Organ Failure/dysfunction syndrome (MOF/MODS)
Time Frame: 2 years
The presence of altered organ function where homeostasis cannot be maintained without intervention using Denver 2 and SOFA scores. For Denver score, MOF is defined as > 3, two (2) organ system involved for 2 consecutive days while in SOFA, MOF> = 4 , two (2) organ system involved for first 24 hours. In the subsequent time points, only cardiac scores for SOFA and Denver 2 are recorded.
2 years
Thromboembolic complications
Time Frame: 2 years
Clinical signs and symptoms associated with thrombosis, i.e., pulmonary embolism, deep vein thrombosis. Clinical investigation to confirm thrombosis will be based on any of the following imaging procedure: CTPA, VQ Scan, USS, Venogram, D-dimer results
2 years
Vancouver Scar Scale (VSS)
Time Frame: 2 years
This scale uses a numerical assessment of four skin characteristics including: Height (range, 0-4), Pliability (range, 0-4), Vascularity (range, 0-3), and Pigmentation (range, 0-3). The assessors choose a numerical value for each of these characteristics based on a comparison with normal skin.
2 years
Patient and Observer Scar Assessment Scale
Time Frame: 2 years
Patient and Observer Scar Assessment Scale (POSAS, version 2.0) - The POSAS questionnaire seeks to measure scar quality and is a subjective scar scale that consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale and together they make up the 'Total Score' of the Patient and Observer Scale. The POSAS Patient scale assesses the scar in terms of pain, itching, scar colour, stiffness, thickness and irregularity and overall opinion. The POSAS Observer scale assesses the scar in terms of vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion.
2 years
Brisbane Burn Scar Impact Profile
Time Frame: 2 years
Brisbane Burn Scar Impact Profile (BBSIP, version 1.0) - This questionnaire assesses the health-related quality of life in people with burn scars. It consists of seven parts which measure; (a) the overall impact of burn scars (itch, pain and other sensations, and their impact on the subject), (b) the impact of the burn scars on work and daily activities, (c) the impact of the burn scars on relationships and social interactions, (d) the subjects perception of the impact of the burn scars on their appearance, (e) the subjects emotional reactions towards their scars and (f) the physical symptoms caused by the burn scars.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Collaborators

University of Birmingham
The Scar Free Foundation

Investigators

  • Principal Investigator: Naiem Moiemen, Surgeon, The Scar Free Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2016

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK5814
  • IRAS Project ID 200366 (Other Identifier: HRA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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