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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Care Group | Experimental | The children will be managed by following standard institutional treatment protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The mortality will be labeled 'yes' if a patient dies within 28 days of admission. | 28 days |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jawaria Ibrahim | Department of Pediatrics, Abbasi Shaheed Hospital Karachi, Pakistan | Principal Investigator |
| Ibrahim Shakoor, FCPS | Department of Pediatrics, Abbasi Shaheed Hospital Karachi, Pakistan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbasi Shaheed Hospital | Karachi | Sindh | 74700 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Drug | The children will be managed by following standard institutional treatment protocol. |
|
| 28 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |