Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock

From Bolus to Infusion: Stress-Dose Steroid Methods and Prognostic Value in Septic Shock Therapy

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 Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Hydrocortisone Continuous Infusion; Drug: Hydrocortisone Intermittent Bolus

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13511
      • Benha University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Hydrocortisone Infusion; 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.	Drug: Hydrocortisone Continuous Infusion; Hydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day.
Active Comparator: Intermittent Hydrocortisone Bolus; 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.	Drug: Hydrocortisone Intermittent Bolus; Hydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): July 1, 2026
• Study Completion (Actual): July 1, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Units; Hydrocortisone; Continuous Intravenous Infusion; Intermittent Bolus Administration; Vasopressor-Dependent Shock; Shock Reversal; Critical Illness-Related Corticosteroid Insufficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: RC.7.2.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No