Paediatric patient undergoing cardiac surgery and other cardiac investigations Circulatory System
Conditions
Interventions
Current interventions as of 11/08/2020:
This is a two-centre descriptive study of the ultradian rhythms of cortisol that occur in neonates, infants and children. Thirty-six patients undergoing cardiac
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the cardiac surgery cohort: Participant may enter study if ALL of the following apply: 1. Age 0-5 or 10-16 years 2. Undergoing cardiac surgery using CPB 3. Weight above 2 kg for neonate patients Inclusion criteria for the cardiac investigation cohort: Participant may enter study if ALL of the following apply: 1. Age 0-5 or 10-16 years 2. Undergoing minimally invasive cardiac investigation with anaesthesia 3. Weight above 2 kg The aim is to recruit patients in each of the following categories: 1. Infants 2. Age 1-5 3. Age 10-16
Exclusion criteria
Exclusion criteria: 1. Emergency investigation 2. Current or recent (within 3 months) use of glucocorticoids 3. Disorders of the HPA axis 4. Thyroid disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The cortisol profile during the 24-hour measurement period for both cohorts. Tissue cortisol levels are measured using subcutaneous microdialysis in all subjects: 2. For the surgical cohort, total serum cortisol will also be measured at 7 timepoints (pre-op assessment, pre-operative – before anaesthesia induction, pre CPB, post CPB, at 6, 12 and 24 hours postop) for infants and pre- and post pubertal children and at 6 time points for neonates (post-CPB sample excluded). These will be correlated with tissue cortisol levels obtained by microdialysis over 24 hours 3. For the cardiac investigation cohort serum cortisol will be measured pre procedure (e.g 1 time point) for all age groups 4. Pulsatility and interaction of cortisol and ACTH as assessed using a bespoke algorithm | — |
Secondary
| Measure | Time frame |
|---|---|
| For the surgical cohort: 1. Adreno-corticotrophic hormone (ACTH), measured by taking blood samples at 7 timepoints (pre-op assessment, pre-operative, pre CPB, post CPB, at 6, 12 and 24 hours postop) for infants and pre- and post pubertal children and at 6 time points for neonates (post-CPB sample excluded) 2. Cortisol Binding Globulin (CBG), measured by taking blood samples at 4 timepoints (pre-op assessment, induction , at 6, and 24 hours postop) for all age groups 3. IL-1, IL-4, IL-6, IL-8, IL-10 and TNF-alpha, measured by taking blood samples at 7 timepoints (pre-op assessment, pre-operative, pre CPB, post CPB, at 6, 12 and 24 hours postop) for infants and pre- and post-pubertal children at and 6 timepoints for neonates (post-CPB sample excluded) 4. FSH, LH and testosterone or estradiol, measured by taking blood samples for 10-16 year olds only (pre-operative – before anaesthesia induction) 5. Death, measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 6. Preoperative biventricular function, measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 7. Cardiac arrest, measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 8. Extracorporeal membrane oxygenation use, measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 9. Renal insufficiency (creatinine more than two times normal), measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 10. Hepatic insufficiency, measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 11. Duration of mechanical ventilation post cardiac surgery, measured using specially designed CRFs (case report forms) collecting data from the date of surgery until discharge 12. Inotrope an | — |
Countries
England, United Kingdom
Contacts
Public ContactJonathan Evans
Outcome results
None listed