Continuous Infusion vs. Intermittent Bolus Hydrocortisone Administration in Children with Catecholamine-Dependent Septic Shock: A Randomized Controlled Trial

Not Applicable

• Conditions: Pediatric septic shock; Septic shock; Hydrocortisone; Children

• Registration Number: TCTR20200715008
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-15
• Study Completion: 2024-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Children 1 month to 18 year of age admitted to PICU with catecholamine-dependent septic shock who are at risk for adrenal insufficiency as followings and received loading dose of hydrocortisone;
Risk for adrenal insufficiency:
- Physical signs e.g. purpura fulminans or diagnosed of Waterhouse-Friderichsen syndrome
- History of hypothalamic-pituitary-adrenal axis abnormalities e.g. congenital adrenal hyperplasia, pituitary gland disease
- History of corticosteroid use either long term (longer than 2 weeks within last 6 months) or short term (not longer than 2 weeks within last 4 month
- History of etomidate use
- History of antifungals use within last 7 days

Exclusion Criteria

Hypersensitivity of hydrocortisone
Do-not-resuscitate patients
Post cardiac arrest
Patient receiving treatment with antifungals for systemic fungal infections at time of randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shock reversal At the time of shock reversal Time to shock reversal from diagnosis of septic shock

Secondary Outcome Measures

Name	Time	Method
Vasoactive-inotropic drug use At day 28 after diagnosis of septic shock Vasoactive-inotropic drug-free days to day 28