Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock

Muhammad Aamir Latif

Status: Not yet enrolling

Conditions: Septic Shock

Treatments: Drug: Standard care; Drug: Intravenous Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT07313670

DR-JAWARIA-KARACHI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 2 months to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Hydrocortisone Group

Experimental group

Description:

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

Treatment:

Drug: Intravenous Hydrocortisone

Drug: Standard care

Standard Care Group

Experimental group

Description:

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

Treatment:

Drug: Standard care