BurnsSIFTI-2NCT04693442
Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries
An observational study of Burns, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- taking of blood, urine and blood samples and objective scar assessment
- How many people
- 245 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2016to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Minnie Ventura, MSc, 01213718220 ext. 18220, Maximina.Ventura@uhb.nhs.uk
Amy Bamford, RN, 01213718226 ext. 18226, Amy.Bamford@uhb.nhs.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns
- Being tested
- taking of blood, urine and blood samples and objective scar assessment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking of blood, urine and blood samples and objective scar assessmentOther
blood, urine and skin tissue sampling \& scar assessment questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Burn patients | with the condition Receives: Other: taking of blood, urine and blood samples and objective scar assessment | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of sepsis
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:
- Temperature (>39°C or <36°C)
- progressive tachycardia (>110 beats per minute
- progressive tachypnea (>25 breaths per minute not ventilated or minute ventilation >12 L/minute ventilated)
- thrombocytopenia (<100,000/μl; not applied until 3 days after initial resuscitation)
- hyperglycaemia (untreated plasma glucose >200 mg/dl, >7 units of insulin/hr intravenous drip, or >25% increase in insulin requirements over 24 hours)
- feed intolerance >24 hours (abdominal distension, residuals two times the feeding rate, or diarrhoea >2500 ml/day)
Measured: 2 years
Secondary outcomes (7)
In-hospital mortality
Death while in-hospital
Measured: 2 years
Predictive mortality scores
Predictive mortality scores are measured by Revised Baux Score, Abbreviated Burn Severity Index (ABSI), and APACHE II
Measured: 2 years
Multiple Organ Failure/dysfunction syndrome (MOF/MODS)
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.
Measured: 2 years
Thromboembolic complications
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
Measured: 2 years
Vancouver Scar Scale (VSS)
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.
Measured: 2 years
Patient and Observer Scar Assessment Scale
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.
Measured: 2 years
Brisbane Burn Scar Impact Profile
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start18 Nov 2016
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Scar Free Foundation, University of Birmingham
- Responsible party
- Principal investigator, Naiem Moiemen, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Naiem Moiemen, Surgeon, Principal investigator, The Scar Free Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693442
- Sponsor's protocol ID
- RRK5814
- Other IDs
- IRAS Project ID 200366
- Acronym
- SIFTI-2
- Status last verified
- Dec 2020
- First submitted
- 16 Apr 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23762773Xiao 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.
PubMed 22110166Jackson 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.
PubMed 23598383Mann 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.
PubMed 21941222Levy 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.
PubMed 12682500Brinkmann 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.
PubMed 15001782Mocsai 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.
PubMed 23825232Butler 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.
PubMed 20689600Arturson 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.
PubMed 4027746Bjerknes R, Vindenes H, Laerum OD. Altered neutrophil functions in patients with large burns. Blood Cells. 1990;16(1):127-41; discussion 142-3.
PubMed 2190644Jones 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.
PubMed 25489947The 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.
PubMed 23140366Tullie 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.
PubMed 40497997Hazeldine 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.
PubMed 34686556
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective Study to Examine the Relationship Between Neutrophil Function and Sepsis in Adults and Children With Severe Thermal Injuries
- ClinicalTrials.gov ID
- NCT04693442
- Acronym / sponsor ID
- SIFTI-2 / RRK5814
- Conditions
- Burns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Collaborators
- The Scar Free Foundation, University of Birmingham
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn patients | – | Other: taking of blood, urine and blood samples and objective scar assessmentwith the condition |
| 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) |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking of blood, urine and blood samples and objective scar assessmentblood, urine and skin tissue sampling \& scar assessment questionnaires | Other | Burn patients |
Primary outcome
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)
7 secondary outcomes
In-hospital mortality
Time frame: 2 years
Predictive mortality scores
Time frame: 2 years
Multiple Organ Failure/dysfunction syndrome (MOF/MODS)
Time frame: 2 years
Thromboembolic complications
Time frame: 2 years
Vancouver Scar Scale (VSS)
Time frame: 2 years
Patient and Observer Scar Assessment Scale
Time frame: 2 years
Brisbane Burn Scar Impact Profile
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 23762773Farina 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.
- Background: PubMed 22110166Xiao 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.
- Background: PubMed 23598383Jackson 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.
- Background: PubMed 21941222Mann 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.
- Background: PubMed 12682500Levy 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.
- Background: PubMed 15001782Brinkmann 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.
- Background: PubMed 23825232Mocsai 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.
- Background: PubMed 20689600Butler 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.
- Background: PubMed 4027746Arturson 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.
- Background: PubMed 2190644Bjerknes R, Vindenes H, Laerum OD. Altered neutrophil functions in patients with large burns. Blood Cells. 1990;16(1):127-41; discussion 142-3.
- Background: PubMed 25489947Jones 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.
- BackgroundThe World Health Organisation. Burns [updated April 2014; cited 2015 06.10.2015]. Available from: http://www.who.int/mediacentre/factsheets/fs365/en/.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naiem Moiemen, Surgeon principal investigator
The Scar Free Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Bamford, Registered Nurse (01213718226 ext. 18226, Amy.Bamford@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of sepsis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693442, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.