Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock

NCT07313670 | Not Yet Recruiting

• 1 other identifier: DR-JAWARIA-KARACHI
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  28 days

Secondary Outcomes (2)

• Duration of vasopressor

  28 days

• Length of pediatric intensive care unit stay

  28 days

Study Arms (2)

Hydrocortisone Group

EXPERIMENTAL

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; Drug: Standard care

Standard Care Group

EXPERIMENTAL

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

Drug: Standard care

Interventions

Standard care DRUG

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

Hydrocortisone Group; Standard Care Group

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.

Hydrocortisone Group

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Abbasi Shaheed Hospital

Karachi, Sindh, 74700, Pakistan

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jawaria Ibrahim

  Abbasi Shaheed Hospital

  PRINCIPAL INVESTIGATOR

• Ibrahim Shakoor, FCPS

  Abbasi Shaheed Hospital

  STUDY DIRECTOR

Central Study Contacts

Jawaria Ibrahim

CONTACT

‪+923212530497; jawariaibrahim22@gmail.com

Ibrahim Shakoor, FCPS

CONTACT

+923002305368; ishakoor@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)