SepsisNCT07869693
Pre-induction Norepinephrine in Septic Patients Undergoing Surgery
A study testing Norepinephrine in people with Sepsis and Hypotension, run by Assiut University.
Trial summary
This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis, Hypotension
- What is being tested?
- Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age 18 to 65 years
- Diagnosed with severe sepsis with SOFA score ≥2
- Scheduled for surgery under general anesthesia
- ASA physical status III or IV
- Written informed consent
Who cannot join
- Severe pre-existing cardiovascular compromise
- Known allergy or hypersensitivity to norepinephrine
- Pregnancy or lactation
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Pre-induction Norepinephrine Initiation on Peri-operative Hemodynamic Stability in Septic Patients With SOFA Score ≥2 Undergoing Surgery Under General Anesthesia
This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia.
Read the detailed description
Induction of general anesthesia in septic patients can cause severe hypotension due to vasodilation and reduced preload. Pre-emptive norepinephrine infusion may prevent post-induction hemodynamic collapse.
This prospective double-blind randomized trial will compare continuous prophylactic norepinephrine infusion started 30 minutes before induction versus standard care with rescue vasopressors only in adult septic patients undergoing surgery.
- Conditions
- Sepsis, Hypotension
- Being tested
- Norepinephrine, Standard Care
- Keywords
- Norepinephrine, Assiut, General anesthesia, Hemodynamic stability, SOFA score, Sepsis
- Medical subject headings
- Sepsis, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Continuous intravenous infusion of norepinephrine.
Standard CareOther
Standard care with rescue vasopressors administered only if hypotension occurs.
| Study group | Role | What they receive |
|---|---|---|
| Early Norepinephrine | Experimental | Continuous intravenous norepinephrine infusion at 0.07 mcg/kg/min initiated 30 minutes before induction of general anesthesia and maintained intraoperatively. Receives: Drug: Norepinephrine |
| Control | Active comparator | No prophylactic norepinephrine before induction. Vasopressors administered only as rescue medication for hypotension. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-induction hypotension
Number of patients with mean arterial pressure drop greater than 20% from baseline or mean arterial pressure less than 65 mmHg within the first 30 minutes after induction of general anesthesia.
Measured: Periprocedurally
Secondary outcomes (4)
Mean arterial pressure
Mean arterial pressure in mmHg.
Measured: Periprocedurally
Total dose of rescue vasopressors
Mean total dose of rescue vasopressors administered intraoperatively in micrograms.
Measured: Immediately after the intervention/procedure/surgery
Total volume of intravenous fluids
Mean total volume of intravenous fluids administered intraoperatively in milliliters.
Measured: Immediately after the intervention/procedure/surgery
Length of ICU stay
Mean length of intensive care unit stay in days.
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofaida mamdouh ashry, Assiut University
- Investigators
- Hamdy A Yousef, prof, Study chair, Anaesthesia , ICU and pain management Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869693
- Sponsor's protocol ID
- NE-Sepsis-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-induction Norepinephrine Initiation on Peri-operative Hemodynamic Stability in Septic Patients With SOFA Score ≥2 Undergoing Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07869693
- Acronym / sponsor ID
- NE-Sepsis-Assiut-2026
- Conditions
- Sepsis, Hypotension
- Keywords
- Norepinephrine, Assiut, General anesthesia, Hemodynamic stability, SOFA score, Sepsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 9 Oct 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.
This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia.
Detailed description
Induction of general anesthesia in septic patients can cause severe hypotension due to vasodilation and reduced preload. Pre-emptive norepinephrine infusion may prevent post-induction hemodynamic collapse.
This prospective double-blind randomized trial will compare continuous prophylactic norepinephrine infusion started 30 minutes before induction versus standard care with rescue vasopressors only in adult septic patients undergoing surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Norepinephrine | Experimental | Drug: NorepinephrineContinuous intravenous norepinephrine infusion at 0.07 mcg/kg/min initiated 30 minutes before induction of general anesthesia and maintained intraoperatively. |
| Control | Active comparator | Other: Standard CareNo prophylactic norepinephrine before induction. Vasopressors administered only as rescue medication for hypotension. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Age 18 to 65 years
- Diagnosed with severe sepsis with SOFA score ≥2
- Scheduled for surgery under general anesthesia
- ASA physical status III or IV
- Written informed consent
Key exclusion criteria (4 listed)
- Severe pre-existing cardiovascular compromise
- Known allergy or hypersensitivity to norepinephrine
- Pregnancy or lactation
- Refusal to participate
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 |
|---|---|---|
| NorepinephrineContinuous intravenous infusion of norepinephrine. | Drug | Early Norepinephrine |
| Standard CareStandard care with rescue vasopressors administered only if hypotension occurs. | Other | Control |
Primary outcome
Incidence of post-induction hypotension
Time frame: Periprocedurally
Number of patients with mean arterial pressure drop greater than 20% from baseline or mean arterial pressure less than 65 mmHg within the first 30 minutes after induction of general anesthesia.
4 secondary outcomes
Mean arterial pressure
Time frame: Periprocedurally
Total dose of rescue vasopressors
Time frame: Immediately after the intervention/procedure/surgery
Total volume of intravenous fluids
Time frame: Immediately after the intervention/procedure/surgery
Length of ICU stay
Time frame: At 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hamdy A Yousef, prof study chair
Anaesthesia , ICU and pain management Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine in people with Sepsis and Hypotension, run by Assiut University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rofaida M ashry, Resident (01003823614, rofaida.ashry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-induction hypotension (time frame: Periprocedurally). 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 15 Oct 2026.