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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200715008
Enrollment
108
Registered
2020-07-15
Start date
2020-06-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric septic shock Septic shock Hydrocortisone Children

Interventions

Continuous infusion hydrocortisone in the dose of 100 mg/m2/day continuous drip in 24 hr until shock reversal with a maximum of 7 days.,Intermittent bolus hydrocortisone in the dose of 25 mg/m2/day q
Active Comparator Drug,Active Comparator Drug
Continuous infusion hydrocortisone ,Intermittent bolus hydrocortisone

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Shock reversal At the time of shock reversal Time to shock reversal from diagnosis of septic shock

Secondary

MeasureTime frame
Vasoactive-inotropic drug use At day 28 after diagnosis of septic shock Vasoactive-inotropic drug-free days to day 28

Countries

Thailand

Contacts

Public ContactNutnicha Preeprem

Siriraj Hospital, Mahidol University

paeng_nutnicha@hotmail.com+66851106914

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026