Septic Shock
Conditions
Keywords
Hydrocortisone, Continuous Intravenous Infusion, Intermittent Bolus Administration, Vasopressor-Dependent Shock, Shock Reversal, Critical Illness-Related Corticosteroid Insufficiency, Intensive Care Units
Brief summary
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.
Interventions
DRUGHydrocortisone Continuous Infusion
Hydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day.
DRUGHydrocortisone Intermittent Bolus
Hydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older of either sex. * Diagnosis of septic shock according to Sepsis-3 criteria, defined as sepsis with persistent hypotension requiring vasopressor therapy to maintain a mean arterial pressure of at least 65 mmHg and a serum lactate level greater than 2 mmol/L despite adequate fluid resuscitation. * Admission to the intensive care unit at Benha University Hospitals.
Exclusion criteria
* Known allergy or contraindication to hydrocortisone. * Known adrenal insufficiency. * Chronic systemic corticosteroid therapy for more than 1 month before enrollment. * Pregnancy or lactation. * Active gastrointestinal bleeding. * Immunosuppression. * Expected survival of less than 24 hours or imminent death from a non-infectious cause. * Psychiatric disorder that could interfere with study participation. * Coagulation disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-Day All-Cause Mortality | At 28 days after ICU admission | Proportion of participants who died from any cause by day 28 after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Shock Reversal Rate | At day 7 after enrollment. | 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. |
| Duration of Septic Shock | Up to day 28 after enrollment. | Number of days from enrollment until reversal of septic shock. |
| Duration of Vasopressor Therapy | Up to day 28 after enrollment. | Number of days during which vasopressor therapy was required after enrollment. |
| Duration of Mechanical Ventilation | Up to day 28 after enrollment. | Number of days requiring invasive mechanical ventilation after enrollment. |
| Intensive Care Unit Length of Stay | Up to day 28 after enrollment. | Number of days from ICU admission until ICU discharge or death. |
| Hospital Length of Stay | Up to day 28 after enrollment. | Number of days from hospital admission until hospital discharge or death. |
| Sequential Organ Failure Assessment Score | Baseline and on days 3 and 5 after enrollment. | 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. |
Countries
Egypt
Outcome results
None listed