Septic ShockPhase 4NCT07695337
Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock
A Phase 4 study testing Hydrocortisone Continuous Infusion and Hydrocortisone Intermittent Bolus in people with Septic Shock, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Hydrocortisone Continuous Infusion and Hydrocortisone Intermittent Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Septic Shock
- Being tested
- Hydrocortisone Continuous Infusion, Hydrocortisone Intermittent Bolus
- Keywords
- Hydrocortisone, Continuous Intravenous Infusion, Intermittent Bolus Administration, Vasopressor-Dependent Shock, Shock Reversal, Critical Illness-Related Corticosteroid Insufficiency, Intensive Care Units
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone Continuous InfusionDrug
Hydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day.
Hydrocortisone Intermittent BolusDrug
Hydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hydrocortisone Intermittent Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day All-Cause Mortality
Proportion of participants who died from any cause by day 28 after enrollment.
Measured: At 28 days after ICU admission
Secondary outcomes (7)
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.
Measured: At day 7 after enrollment.
Duration of Septic Shock
Number of days from enrollment until reversal of septic shock.
Measured: Up to day 28 after enrollment.
Duration of Vasopressor Therapy
Number of days during which vasopressor therapy was required after enrollment.
Measured: Up to day 28 after enrollment.
Duration of Mechanical Ventilation
Number of days requiring invasive mechanical ventilation after enrollment.
Measured: Up to day 28 after enrollment.
Intensive Care Unit Length of Stay
Number of days from ICU admission until ICU discharge or death.
Measured: Up to day 28 after enrollment.
Hospital Length of Stay
Number of days from hospital admission until hospital discharge or death.
Measured: 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.
Measured: Baseline and on days 3 and 5 after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jan 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Eldesouki, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695337
- Sponsor's protocol ID
- RC.7.2.2026
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Bolus to Infusion: Stress-Dose Steroid Methods and Prognostic Value in Septic Shock Therapy
- ClinicalTrials.gov ID
- NCT07695337
- Acronym / sponsor ID
- RC.7.2.2026
- Conditions
- Septic Shock
- Keywords
- Hydrocortisone, Continuous Intravenous Infusion, Intermittent Bolus Administration, Vasopressor-Dependent Shock, Shock Reversal, Critical Illness-Related Corticosteroid Insufficiency, Intensive Care Units
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous Hydrocortisone Infusion | Experimental | Drug: Hydrocortisone Continuous InfusionParticipants 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. |
| Intermittent Hydrocortisone Bolus | Active comparator | Drug: Hydrocortisone Intermittent BolusParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone Continuous InfusionHydrocortisone was administered intravenously as a continuous infusion at a total dose of 200 mg per day. | Drug | Continuous Hydrocortisone Infusion |
| Hydrocortisone Intermittent BolusHydrocortisone was administered intravenously as 50 mg every 6 hours, for a total dose of 200 mg per day. | Drug | Intermittent Hydrocortisone Bolus |
Primary outcome
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.
7 secondary outcomes
7-Day Shock Reversal Rate
Time frame: At day 7 after enrollment.
Duration of Septic Shock
Time frame: Up to day 28 after enrollment.
Duration of Vasopressor Therapy
Time frame: Up to day 28 after enrollment.
Duration of Mechanical Ventilation
Time frame: Up to day 28 after enrollment.
Intensive Care Unit Length of Stay
Time frame: Up to day 28 after enrollment.
Hospital Length of Stay
Time frame: Up to day 28 after enrollment.
Sequential Organ Failure Assessment Score
Time frame: Baseline and on days 3 and 5 after enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone Continuous Infusion and Hydrocortisone Intermittent Bolus in people with Septic Shock, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day All-Cause Mortality (time frame: At 28 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.