Skip to main content
OpenTrials
Completed

NCT Number: NCT07313670

Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbasi Shaheed Hospital

Karachi, Sindh, 74700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Hydrocortisone

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

Drug

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

Primary outcomes

  1. Mortality

    Time frame: 28 days

    The mortality will be labeled 'yes' if a patient dies within 28 days of admission.

Secondary outcomes

  1. Duration of vasopressor

    Time frame: 28 days

    Vasopressor therapy time will be computed from the start of treatment until hemodynamic stability is attained.

  2. Length of pediatric intensive care unit stay

    Time frame: 28 days

    The time will be calculated from admission in the pediatric intensive care unit until discharge or mortality.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.