Critical Illness Clinical Trial
— BASICOfficial title:
Biomarkers of Acute Serious Illness in Children (BASIC): Understanding the Genetic Basis and Biological Pathways Underlying Critical Illness and How They Influence Outcome in Children Requiring Emergency Intensive Care
NCT number | NCT03238040 |
Other study ID # | 13SG19 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2014 |
Est. completion date | December 31, 2017 |
Verified date | October 2022 |
Source | Great Ormond Street Hospital for Children NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a large multi-centre collaboration between a busy regional paediatric intensive care transport service (Children's Acute Transport Service, CATS), four large paediatric intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of Paediatrics at Imperial College, London. CATS transports over 800 sick children on life support to the three PICUs each year. We aim to improve our understanding of the genetic basis and biological pathways by which children with acute infection or injury become critically ill and develop failure of vital organs, and how these factors influence outcome. We will establish well-characterised cohorts of sick children with diverse pathologies, in whom blood, urine and other samples will be collected at an early stage of critical illness. Samples will be analysed using genomic, transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will be used to identify biomarkers for early diagnosis and robust risk stratification. We will focus on biomarkers to help distinguish between serious bacterial infections, viral infections and other causes of critical illness; diagnose incipient organ failure; and accurately identify, early on, children at high risk of developing a poor outcome. We will recruit critically ill children at first contact with the CATS team, during emergency transport to PICU. Due to the emergency nature of the research, and minimal risk associated with the study procedure, we will seek deferred, written informed consent from parents/guardians once their child has been stabilised, within 24-48 hours following PICU admission. By studying these important questions, we aim to better understand how we can diagnose and provide early life-saving treatments to critically ill children. The research team have an established track record of successful completion of several large clinical studies in critical care as well as validation of biomarkers in other diseases.
Status | Completed |
Enrollment | 674 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 16 Years |
Eligibility | Inclusion Criteria: - Critically ill children aged 0-16 years requiring emergency transfer by the Children's Acute Transport Service (CATS) to participating paediatric intensive care units - Presence of an indwelling catheter (arterial and/or venous) for blood sampling - Presence of a urinary catheter for urine sample collection. Exclusion Criteria: - CATS transfers to other intensive care units or non-intensive care destination units - Premature newborns (under 36 weeks corrected gestational age) - Children with a known do-not-resuscitate (DNR) order in place. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Trust | Cambridge | |
United Kingdom | Barts Health NHS Trust | London | |
United Kingdom | Great Ormond Street Hospital for Children NHS Foundation Trust | London | |
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Great Ormond Street Hospital for Children NHS Foundation Trust | Barts & The London NHS Trust, Imperial College Healthcare NHS Trust, Imperial College London, University of Cambridge |
United Kingdom,
Feinstein Y, Walker JC, Peters MJ, Nadel S, Pathan N, Edmonds N, Herberg J, Kaforou M, Wright V, Levin M, Ramnarayan P. Cohort profile of the Biomarkers of Acute Serious Illness in Children (BASIC) study: a prospective multicentre cohort study in critically ill children. BMJ Open. 2018 Nov 8;8(11):e024729. doi: 10.1136/bmjopen-2018-024729. — View Citation
Kean IRL, Wagner J, Wijeyesekera A, De Goffau M, Thurston S, Clark JA, White DK, Ridout J, Agrawal S, Kayani R, O'Donnell R, Ramnarayan P, Peters MJ, Klein N, Holmes E, Parkhill J, Baker S, Pathan N. Profiling gut microbiota and bile acid metabolism in cr — View Citation
Wijeyesekera A, Wagner J, De Goffau M, Thurston S, Rodrigues Sabino A, Zaher S, White D, Ridout J, Peters MJ, Ramnarayan P, Branco RG, Torok ME, Valla F, Meyer R, Klein N, Frost G, Parkhill J, Holmes E, Pathan N. Multi-Compartment Profiling of Bacterial a — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of bacterial infection | Diagnosis of a bacterial infection by laboratory tests (culture, molecular diagnostics) | From recruitment until PICU discharge or up to 28 days, whichever occurs earlier | |
Primary | Multiorgan failure | Failure of two or more organs using the PELOD score | From recruitment until PICU discharge or up to 28 days, whichever occurs earlier | |
Primary | Poor outcome at intensive care unit discharge | Mortality or development of severe disability | From recruitment until PICU discharge or up to 28 days, whichever occurs earlier | |
Secondary | Long term health related quality of life | Health related quality of life assessed by the age-appropriate Peds-QL questionnaire completed by parent proxy | 12 months after PICU discharge | |
Secondary | Long term behavioural outcome | Behavioural status assessed by the age-appropriate Child Behaviour Checklist completed by parent proxy | 12 months after PICU discharge |
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