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Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock

9. juli 2026 opdateret af: Ahmed Eldesouki, Benha University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Fase 4

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

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Berettigelseskriterier

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Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Hydrocortisone Continuous Infusion
Hydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day.
Aktiv komparator: 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.
Medicin: Hydrocortisone Intermittent Bolus
Hydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28-Day All-Cause Mortality
Tidsramme: At 28 days after ICU admission
Proportion of participants who died from any cause by day 28 after enrollment.
At 28 days after ICU admission

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
7-Day Shock Reversal Rate
Tidsramme: 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.
At day 7 after enrollment.
Duration of Septic Shock
Tidsramme: Up to day 28 after enrollment.
Number of days from enrollment until reversal of septic shock.
Up to day 28 after enrollment.
Duration of Vasopressor Therapy
Tidsramme: Up to day 28 after enrollment.
Number of days during which vasopressor therapy was required after enrollment.
Up to day 28 after enrollment.
Duration of Mechanical Ventilation
Tidsramme: Up to day 28 after enrollment.
Number of days requiring invasive mechanical ventilation after enrollment.
Up to day 28 after enrollment.
Intensive Care Unit Length of Stay
Tidsramme: Up to day 28 after enrollment.
Number of days from ICU admission until ICU discharge or death.
Up to day 28 after enrollment.
Hospital Length of Stay
Tidsramme: Up to day 28 after enrollment.
Number of days from hospital admission until hospital discharge or death.
Up to day 28 after enrollment.
Sequential Organ Failure Assessment Score
Tidsramme: 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.
Baseline and on days 3 and 5 after enrollment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Benha University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Faktiske)

1. juli 2026

Studieafslutning (Faktiske)

1. juli 2026

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC.7.2.2026

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Septisk chok

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