Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07313670

Enrollment

122

Registered

2026-01-02

Start date

2025-07-01

Completion date

2025-12-30

Last updated

2026-06-29

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

Conditions

Septic Shock

Brief summary

Although, hydrocortisone has shown promise in managing refractory shock, its role in early septic shock management remains unclear. This study aims to provide robust evidence on the clinical and hemodynamic outcomes of early hydrocortisone use in pediatric septic shock, contributing to standardized treatment protocols and improved survival rates.

Detailed description

Despite global advancements in pediatric critical care, mortality and morbidity in septic shock remain unacceptably high. Although data suggest a reduction in mortality with steroid therapy in refractory shock, specific data for hydrocortisone in pediatrics are limited. The findings of this study would not only be a valuable addition to the existing stats but might also help develop a protocol for the use of hydrocortisone therapy in children with septic shock, seeking an earlier recovery from organ failure, earlier reversal of shock, and lower mortality in children with sepsis and septic shock.

Interventions

DRUGIntravenous Hydrocortisone

Children will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock.

DRUGStandard care

The children will be managed by following standard institutional treatment protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Months to 12 Years

Healthy volunteers

Inclusion criteria

* Children of any gender * Aged 2 month to 12 years * Diagnosed with septic shock * Admitted to the pediatric intensive care unit

Exclusion criteria

* Known adrenal insufficiency or congenital adrenal hyperplasia * History of corticosteroid use within the past 7 days * Terminal illness or "do-not-resuscitate (DNR)" status * Severe immunocompromise (e.g., advanced malignancy, HIV stage IV) * Known allergy to hydrocortisone

Design outcomes

Primary

Measure	Time frame	Description
Mortality	28 days	The mortality will be labeled 'yes' if a patient dies within 28 days of admission.

Secondary

Measure	Time frame	Description
Duration of vasopressor	28 days	Vasopressor therapy time will be computed from the start of treatment until hemodynamic stability is attained.
Length of pediatric intensive care unit stay	28 days	The time will be calculated from admission in the pediatric intensive care unit until discharge or mortality.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORJawaria Ibrahim

Department of Pediatrics, Abbasi Shaheed Hospital Karachi, Pakistan

STUDY_DIRECTORIbrahim Shakoor, FCPS