Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock

NCT07695337 | Completed Phase 4

• 1 other identifier: RC.7.2.2026
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Hydrocortisone; Continuous Intravenous Infusion; Intermittent Bolus Administration; Vasopressor-Dependent Shock; Shock Reversal; Critical Illness-Related Corticosteroid Insufficiency; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 7-Day Shock Reversal Rate

  At day 7 after enrollment.

• Duration of Septic Shock

  Up to day 28 after enrollment.

• Duration of Vasopressor Therapy

  Up to day 28 after enrollment.

• Duration of Mechanical Ventilation

  Up to day 28 after enrollment.

• Intensive Care Unit Length of Stay

  Up to day 28 after enrollment.

Study Arms (2)

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.

Drug: Hydrocortisone Continuous Infusion

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.

Drug: Hydrocortisone Intermittent Bolus

Interventions

Hydrocortisone Continuous Infusion DRUG

Hydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day.

Continuous Hydrocortisone Infusion

Hydrocortisone Intermittent Bolus DRUG

Hydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day.

Intermittent Hydrocortisone Bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Critical Care Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: January 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)