Catecholamine-
Conditions
Interventions
Hydrocortisone 100 mg/m2 of BSA /dose (max 200 mg/dose ) IV bolus will be administered then reduced to 25 mg/m2 of BSA /dose (max 50 mg/dose ) IV q 6 hr. If patients do not require fluid bolus and/o
inotropic support,
the dosing frequency will be reduced to q 8hr. The drug will be discontinued if the patients do not require vasoactive-
inotropic support at least 12 hours. The total course of therapy will be a maximum of 7 days.,Vials containing placebo will be identical to those containing hydrocortisone.
Placebo 100 mg/m2 of BSA /d
inotropic support at least 12 hours. The total course of therapy will be a maximum of 7 days.
Experimental Drug,Placebo Comparator Drug
hydrocortisone,placebol
Sponsors
Siriraj research development fund (managed by routine to research)
Eligibility
Sex/Gender
All
Age
6 Months to 18 Years
Inclusion criteria
Inclusion criteria: All children 6 months – 18 years of age with septic shock who require vasoactive-inotropic support in the pediatric ICU
Exclusion criteria
Exclusion criteria: •Pre-existing hypothalamic-pituitary-adrenal axis dysfunction •History of long term corticosteroid use within 6 months or short term corticosteroid use within past 4 weeks •History of etomidate or ketonazole use within past 7 days •HIV infection •Skin lesion described as purpura fulminans •History of receiving vasoactive-inotropic drugs > 24 hours before enrollment •Diabetes mellitus •Blood sugar ≥180 mg/dL before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to shock reversal until dischagre form ICU Time to maintain SBP > 5th percentile + without vasoactive-inotropic support for at least 24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of PICU stay ICU admission date to ICU discharge date days,Length of hospital stay until discharge from hospital days,28 day-mortality Death from any causes at 28 days after enrollment Mortality rate ,Continuous renal replacement therapy requirement Until discharge form ICU The proportion of CRRT patients,Blood product requirement Until dischagre form ICU The proportion of required blood transfusion patients,Organ dysfunction free days Free from organ failure at 28 days after enrollment days,Adverse effects Adverse effects at 7 days after enrollment The proportion of adverse effects | — |
Countries
Thailand
Contacts
Public ContactSuwannee Phumeetham
Faculty of Medicine Siriraj hospital, Mahidol University
Outcome results
None listed