Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock

Benha University110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Septic Shock

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

28-Day All-Cause Mortality

Proportion of participants who died from any cause by day 28 after enrollment.

Time frame: At 28 days after ICU admission

Secondary Outcomes

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.

Time frame: At day 7 after enrollment.

Duration of Septic Shock

Number of days from enrollment until reversal of septic shock.