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Septic shock is a life-threatening condition in which infection causes dangerously low blood pressure and organ dysfunction despite fluid resuscitation and vasopressor treatment. Hydrocortisone is commonly used in patients with septic shock who continue to require vasopressors. However, it is uncertain whether hydrocortisone should be administered as a continuous intravenous infusion or as intermittent intravenous bolus doses.
This randomized controlled trial evaluates whether continuous intravenous hydrocortisone infusion improves clinical outcomes compared with intermittent intravenous hydrocortisone boluses in adult patients with septic shock. Participants receive either hydrocortisone 200 mg/day by continuous infusion or hydrocortisone 50 mg intravenously every 6 hours, in addition to standard septic shock management. The study evaluates 28-day mortality, recovery from shock, duration of vasopressor therapy, mechanical ventilation duration, intensive care unit stay, hospital stay, inflammatory markers, and organ dysfunction scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Hydrocortisone Infusion | Experimental | Participants received intravenous hydrocortisone as a continuous infusion at a total dose of 200 mg/day, in addition to standard septic shock management, including antimicrobial therapy, fluid resuscitation, vasopressors, source control when indicated, and organ-supportive care. |
|
| Intermittent Hydrocortisone Bolus | Active Comparator | Participants received intravenous hydrocortisone 50 mg every 6 hours, for a total dose of 200 mg/day, in addition to standard septic shock management, including antimicrobial therapy, fluid resuscitation, vasopressors, source control when indicated, and organ-supportive care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone Continuous Infusion | Drug | Hydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-Day All-Cause Mortality | Proportion of participants who died from any cause by day 28 after enrollment. | At 28 days after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Shock Reversal Rate | Proportion of participants who achieved reversal of septic shock, defined as discontinuation of vasopressor therapy while maintaining a mean arterial pressure of at least 65 mmHg. | At day 7 after enrollment. |
| Duration of Septic Shock |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospitals | Banhā | Qalyubia Governorate | 13511 | Egypt |
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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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Participants were randomly assigned in a 1:1 ratio to receive either continuous intravenous hydrocortisone infusion at a total dose of 200 mg/day or intermittent intravenous hydrocortisone boluses of 50 mg every 6 hours, in addition to standard septic shock management.
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Outcome assessors were unaware of participants' treatment assignments. Treatment allocation was maintained by an independent coordinator who was not involved in clinical management or outcome assessment.
| Hydrocortisone Intermittent Bolus | Drug | Hydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day. |
|
Number of days from enrollment until reversal of septic shock. |
| Up to day 28 after enrollment. |
| Duration of Vasopressor Therapy | Number of days during which vasopressor therapy was required after enrollment. | Up to day 28 after enrollment. |
| Duration of Mechanical Ventilation | Number of days requiring invasive mechanical ventilation after enrollment. | Up to day 28 after enrollment. |
| Intensive Care Unit Length of Stay | Number of days from ICU admission until ICU discharge or death. | Up to day 28 after enrollment. |
| Hospital Length of Stay | Number of days from hospital admission until hospital discharge or death. | Up to day 28 after enrollment. |
| Sequential Organ Failure Assessment Score | Total Sequential Organ Failure Assessment (SOFA) score, expressed as a numerical score ranging from 0 to 24 points. The SOFA score assesses the degree of organ dysfunction across six organ systems. A score of 0 indicates no organ dysfunction, while higher numerical scores indicate more severe organ dysfunction and a worse clinical condition. | Baseline and on days 3 and 5 after enrollment. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |