Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydrocortisone Group

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

Group Type EXPERIMENTAL

Intravenous Hydrocortisone

Intervention Type DRUG

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

Standard care

Intervention Type DRUG

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

Standard Care Group

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

Group Type EXPERIMENTAL

Standard care

Intervention Type DRUG

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

Interventions

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Intravenous 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.

Intervention Type DRUG

Standard care

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No