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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Intravenous Hydrocortisone; Drug: Standard care

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.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jawaria Ibrahim; Phone Number: +923212530497; Email: jawariaibrahim22@gmail.com
• Study Contact Backup: Name: Ibrahim Shakoor, FCPS; Phone Number: +923002305368; Email: ishakoor@yahoo.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74700
      • Abbasi Shaheed Hospital
      • Contact: Jawaria Ibrahim; Phone Number: +923212530497; Email: jawariaibrahim22@gmail.com
      • Contact: Ibrahim Shakoor, PCPS; Phone Number: +923002305368; Email: ishakoor@yahoo.com
      • Principal Investigator: Jawaria Ibrahim
      • Principal Investigator: Ibrahim Shakoor, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Drug: Standard care; The children will be managed by following standard institutional treatment protocol.
Experimental: Standard Care Group; The children will be managed by following standard institutional treatment protocol.	Drug: Standard care; The children will be managed by following standard institutional treatment protocol.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Jawaria Ibrahim, Abbasi Shaheed Hospital; Study Director: Ibrahim Shakoor, FCPS, Abbasi Shaheed Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: DR-JAWARIA-KARACHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No