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NCT Number: NCT07695337

Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benha University Hospitals

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrocortisone Continuous Infusion

Drug

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

Hydrocortisone Intermittent Bolus

Drug

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

Primary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: At 28 days after ICU admission

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

Secondary outcomes

  1. 7-Day Shock Reversal Rate

    Time frame: 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.

  2. Duration of Septic Shock

    Time frame: Up to day 28 after enrollment.

    Number of days from enrollment until reversal of septic shock.

  3. Duration of Vasopressor Therapy

    Time frame: Up to day 28 after enrollment.

    Number of days during which vasopressor therapy was required after enrollment.

  4. Duration of Mechanical Ventilation

    Time frame: Up to day 28 after enrollment.

    Number of days requiring invasive mechanical ventilation after enrollment.

  5. Intensive Care Unit Length of Stay

    Time frame: Up to day 28 after enrollment.

    Number of days from ICU admission until ICU discharge or death.

  6. Hospital Length of Stay

    Time frame: Up to day 28 after enrollment.

    Number of days from hospital admission until hospital discharge or death.

  7. Sequential Organ Failure Assessment Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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