Peacock - a paediatric cortisol study

Not Applicable

Completed

• Conditions: Paediatric patient undergoing cardiac surgery and other cardiac investigations; Circulatory System

• Registration Number: ISRCTN98258655
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32450805/ (added 28/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Study Completion: 2022-12-01
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

1. Emergency investigation
2. Current or recent (within 3 months) use of glucocorticoids
3. Disorders of the HPA axis
4. Thyroid disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The cortisol profile during the 24-hour measurement period for both cohorts. Tissue cortisol levels are measured using subcutaneous microdialysis in all subjects:<br>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<br>3. For the cardiac investigation cohort serum cortisol will be measured pre procedure (e.g 1 time point) for all age groups<br>4. Pulsatility and interaction of cortisol and ACTH as assessed using a bespoke algorithm