Septic ShockPhase 4NCT06915506
Shenfu Injection Modulates Carotid Elasticity in Septic Shock
A Phase 4 study testing Shenfu Injection in people with Septic Shock and Vascular Dysfunction, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
What is this study about? We are studying whether Shenfu Injection (a traditional Chinese herbal medicine) can help improve blood vessel health in patients with septic shock-a severe complication of infections that can damage blood vessels and organs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock, Vascular Dysfunction, Arterial Stiffness
- What is being tested?
- Shenfu Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 30 Apr 2026
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of sepsis or septic shock in the acute phase, as defined by the -Sepsis-3 criteria (confirmed infection with Sequential Organ Failure Assessment [SOFA] score ≥ 2 points above baseline).
- Voluntary participation with written informed consent provided by the patient or legally authorized representative.
Who cannot join
- Severe carotid atherosclerosis (e.g., carotid Intima-Media Thickness (IMT)>1.2 mm or confirmed plaque formation) diagnosed by prior imaging.
- Significant cardiovascular comorbidities that may confound hemodynamic assessments, including:
- Severe cardiomyopathy (e.g., ejection fraction <30%).
- Uncontrolled arrhythmias (e.g., ventricular tachycardia, atrial fibrillation with rapid ventricular response).
- Congenital heart disease with hemodynamic instability.
- Active hepatic or renal insufficiency (e.g., Child-Pugh class C, dialysis dependence) or advanced systemic diseases (e.g., metastatic malignancy, terminal illness).
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- Poor ultrasound image quality precluding reliable speckle tracking analysis (e.g., inadequate acoustic window, motion artifacts).
- Pregnancy or lactation (due to potential hormonal influences on vascular physiology).
- Withdrawal from the study or inability to complete follow-up assessments (e.g., non-compliance, transfer to another facility).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241000
Shengsheng Tao, 86-18315329399, taoshengsheng@yjsyy.com
About this study
Official title: The Effect of Shenfu Injection on Carotid Artery Elasticity in Septic Shock Patients: A Prospective Observational Pilot Study
What is this study about? We are studying whether Shenfu Injection (a traditional Chinese herbal medicine) can help improve blood vessel health in patients with septic shock-a severe complication of infections that can damage blood vessels and organs. Specifically, we want to see if this treatment makes the carotid artery (a major neck blood vessel) more flexible and resilient, which may support recovery.
Who can join? Adults (18 years or older) diagnosed with septic shock by their doctors. Patients whose doctors plan to use Shenfu Injection as part of their treatment. Patients who agree to participate and sign a consent form. Who cannot join? Patients with severe heart conditions, advanced organ failure, or major neck artery disease.
Read more
Pregnant or breastfeeding women. Those unable to complete the study procedures. What will happen during the study?
Safe and Pain-Free Tests:
Ultrasound scans: A non-invasive imaging method will be used to measure the flexibility and blood flow of your neck artery.
Advanced imaging technology: A special ultrasound technique (called speckle tracking) will take detailed pictures of your artery's movement during heartbeat cycles.
Timing of Tests:
Scans will be done before receiving Shenfu Injection and 1, 2, 3 hours after the injection, plus 1 hour after treatment ends.
Other Data Collection:
Blood tests to check inflammation and organ function. Recording your health status (e.g., blood pressure, heart rate) and recovery progress (e.g., time in the Intensive Care Unit (ICU), survival rates).
What are the benefits and risks? Benefits: This study may help doctors better understand how Shenfu Injection works and improve future care for septic shock patients.
Risks: The ultrasound scans are routine, safe, and painless. There is no extra risk beyond standard hospital care.
Your Rights and Safety Voluntary Participation: You can withdraw at any time without affecting your treatment.
Ethical Approval: This study is reviewed and approved by the hospital's ethics committee.
Privacy: Your personal information and test results will be kept confidential.
- Conditions
- Septic Shock, Vascular Dysfunction, Arterial Stiffness, Carotid Artery Elasticity Alterations, Sepsis
- Being tested
- Shenfu Injection
- Keywords
- Septic shock, Shenfu Injection, Carotid artery elasticity, Ultrasound speckle tracking, Vascular dysfunction, Arterial stiffness, Strain imaging, Traditional Chinese Medicine (TCM), Circumferential strain (CS), Sepsis-associated vascular injury
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenfu InjectionDrug
This intervention combines traditional Chinese medicine (TCM) with modern critical care practices to distinguish it from conventional sepsis therapies. Key unique features include:
TCM-Based Intervention:
Shenfu Injection: A standardized herbal extract derived from Panax ginseng and Aconitum carmichaelii , prepared under Chinese Pharmacopoeia guidelines.
Mechanism: Targets mitochondrial dysfunction and endothelial glycocalyx repair, with preclinical evidence of anti-inflammatory, anti-apoptotic, and vasoregulatory effects.
Precision Delivery Protocol:
Dosage: 60 mL (1 mL/kg for patients <60 kg) administered via syringe pump-controlled continuous infusion over 3 hours, ensuring stable plasma concentrations.
Timing: Initiated only after hemodynamic stabilization (≥1 hour of stable vasopressor requirements post-fluid resuscitation), aligning with the "golden window" for vascular repair in sepsis.
| Study group | Role | What they receive |
|---|---|---|
| Shenfu Injection Group | Experimental | Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. Following completion of fluid resuscitation and confirmation of hemodynamic stability (maintained for ≥1 hour with vasoactive agents), Shenfu Injection will be administered at a dose of 60 mL via continuous infusion over 3 hours using a syringe pump. Carotid artery circumferential strain will be quantitatively assessed using ultrasound Speckle Tracking Imaging (STI) at the following five time points to evaluate carotid artery elasticity:
T0: Pre-administration baseline T1: 1 hour post-administration initiation T2: 2 hours post-administration initiation T3: 3 hours post-administration initiation (end of infusion) T4: 1 hour post-infusion completion Receives: Drug: Shenfu Injection |
| Control Group | No intervention | Patients in this group will receive standard sepsis management strictly adhering to international and Chinese guidelines. Following completion of fluid resuscitation and confirmation of hemodynamic stability (defined as ≥1 hour of stable vasoactive agent requirements without dose escalation), carotid artery circumferential strain will be serially assessed using ultrasound speckle tracking imaging (STI) to evaluate vascular elasticity. Measurements will be performed at five predefined time points aligned with the intervention group's protocol: T0: Baseline (immediately post-stabilization) T1: 1 hour post-T0 T2: 2 hours post-T0 T3: 3 hours post-T0 T4: 4 hours post-T0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Artery Circumferential Strain (CS)
Peak deformation of the carotid artery wall during the cardiac cycle, measured via ultrasound speckle tracking imaging (STI).Derived from strain rate analysis using dedicated vascular ultrasound software.
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Elasticity (Beta (β)2 Stiffness Index)
Description: Composite metric integrating blood pressure and circumferential strain to quantify vascular stiffness.
Calculation: β 2= ln(Systolic Blood Pressure/Diastolic Blood Pressure)/CS Data Sources: Blood pressure (non-invasive monitoring) + STI-derived CS.
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Secondary outcomes (7)
Carotid Artery Elasticity (β1 Stiffness Index)
Calculation：β 1 = ln(Systolic Blood Pressure/Diastolic Blood Pressure)/(Ds-Dd)×Dd
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Systolic Diameter (Ds)
Maximum diameter during systole (millimeters, mm)
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Diastolic Diameter (Dd)
Minimum diameter during diastole (millimeters, mm)
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Peak Systolic Velocity (PSV)
Parameter: Maximum flow velocity during systole by Doppler Ultrasound Unit: cm/s Measurement**: Pulsed-wave Doppler spectral analysis
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery End-Diastolic Velocity (EDV)
Parameter: Minimum flow velocity at end-diastole by Doppler Ultrasound Unit: cm/s Measurement**: Pulsed-wave Doppler spectral analysis
Measured: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
ICU Length of Stay
Days from enrollment to ICU discharge.
Measured: up to 28 days
28-Day All-Cause Mortality
Survival status at 28 days post-enrollment.
Measured: Day 28 post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
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.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhu City Second People's Hospital
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915506
- Sponsor's protocol ID
- 202506
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shenfu Injection on Carotid Artery Elasticity in Septic Shock Patients: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06915506
- Acronym / sponsor ID
- 202506
- Conditions
- Septic Shock, Vascular Dysfunction, Arterial Stiffness, Carotid Artery Elasticity Alterations, Sepsis
- Keywords
- Septic shock, Shenfu Injection, Carotid artery elasticity, Ultrasound speckle tracking, Vascular dysfunction, Arterial stiffness, Strain imaging, Traditional Chinese Medicine (TCM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- Wuhu City Second People's Hospital
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
What is this study about? We are studying whether Shenfu Injection (a traditional Chinese herbal medicine) can help improve blood vessel health in patients with septic shock-a severe complication of infections that can damage blood vessels and organs. Specifically, we want to see if this treatment makes the carotid artery (a major neck blood vessel) more flexible and resilient, which may support recovery.
Who can join? Adults (18 years or older) diagnosed with septic shock by their doctors. Patients whose doctors plan to use Shenfu Injection as part of their treatment. Patients who agree to participate and sign a consent form. Who cannot join? Patients with severe heart conditions, advanced organ failure, or major neck artery disease.
Pregnant or breastfeeding women. Those unable to complete the study procedures. What will happen during the study?
Safe and Pain-Free Tests:
Ultrasound scans: A non-invasive imaging method will be used to measure the flexibility and blood flow of your neck artery.
Advanced imaging technology: A special ultrasound technique (called speckle tracking) will take detailed pictures of your artery's movement during heartbeat cycles.
Timing of Tests:
Scans will be done before receiving Shenfu Injection and 1, 2, 3 hours after the injection, plus 1 hour after treatment ends.
Other Data Collection:
Blood tests to check inflammation and organ function. Recording your health status (e.g., blood pressure, heart rate) and recovery progress (e.g., time in the Intensive Care Unit (ICU), survival rates).
What are the benefits and risks? Benefits: This study may help doctors better understand how Shenfu Injection works and improve future care for septic shock patients.
Risks: The ultrasound scans are routine, safe, and painless. There is no extra risk beyond standard hospital care.
Your Rights and Safety Voluntary Participation: You can withdraw at any time without affecting your treatment.
Ethical Approval: This study is reviewed and approved by the hospital's ethics committee.
Privacy: Your personal information and test results will be kept confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shenfu Injection Group | Experimental | Drug: Shenfu InjectionTreatment will be conducted in accordance with international and Chinese guidelines for sepsis. Following completion of fluid resuscitation and confirmation of hemodynamic stability (maintained for ≥1 hour with vasoactive agents), Shenfu Injection will be administered at a dose of 60 mL via continuous infusion over 3 hours using a syringe pump. Carotid artery circumferential strain will be quantitatively assessed using ultrasound Speckle Tracking Imaging (STI) at the following five time points to evaluate carotid artery elasticity: T0: Pre-administration baseline T1: 1 hour post-administration initiation T2: 2 hours post-administration initiation T3: 3 hours post-administration initiation (end of infusion) T4: 1 hour post-infusion completion |
| Control Group | No intervention | –Patients in this group will receive standard sepsis management strictly adhering to international and Chinese guidelines. Following completion of fluid resuscitation and confirmation of hemodynamic stability (defined as ≥1 hour of stable vasoactive agent requirements without dose escalation), carotid artery circumferential strain will be serially assessed using ultrasound speckle tracking imaging (STI) to evaluate vascular elasticity. Measurements will be performed at five predefined time points aligned with the intervention group's protocol: T0: Baseline (immediately post-stabilization) T1: 1 hour post-T0 T2: 2 hours post-T0 T3: 3 hours post-T0 T4: 4 hours post-T0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Diagnosis of sepsis or septic shock in the acute phase, as defined by the -Sepsis-3 criteria (confirmed infection with Sequential Organ Failure Assessment [SOFA] score ≥ 2 points above baseline).
- Voluntary participation with written informed consent provided by the patient or legally authorized representative.
Key exclusion criteria (9 listed)
- Severe carotid atherosclerosis (e.g., carotid Intima-Media Thickness (IMT)>1.2 mm or confirmed plaque formation) diagnosed by prior imaging.
- Significant cardiovascular comorbidities that may confound hemodynamic assessments, including:
- Severe cardiomyopathy (e.g., ejection fraction <30%).
- Uncontrolled arrhythmias (e.g., ventricular tachycardia, atrial fibrillation with rapid ventricular response).
- Congenital heart disease with hemodynamic instability.
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 |
|---|---|---|
| Shenfu InjectionThis intervention combines traditional Chinese medicine (TCM) with modern critical care practices to distinguish it from conventional sepsis therapies. Key unique features include: TCM-Based Intervention: Shenfu Injection: A standardized herbal extract derived from Panax ginseng and Aconitum carmichaelii , prepared under Chinese Pharmacopoeia guidelines. Mechanism: Targets mitochondrial dysfunction and endothelial glycocalyx repair, with preclinical evidence of anti-inflammatory, anti-apoptotic, and vasoregulatory effects. Precision Delivery Protocol: Dosage: 60 mL (1 mL/kg for patients <60 kg) administered via syringe pump-controlled continuous infusion over 3 hours, ensuring stable plasma concentrations. Timing: Initiated only after hemodynamic stabilization (≥1 hour of stable vasopressor requirements post-fluid resuscitation), aligning with the "golden window" for vascular repair in sepsis. | Drug | Shenfu Injection Group |
Primary outcome
Carotid Artery Circumferential Strain (CS)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Peak deformation of the carotid artery wall during the cardiac cycle, measured via ultrasound speckle tracking imaging (STI).Derived from strain rate analysis using dedicated vascular ultrasound software.
Carotid Artery Elasticity (Beta (β)2 Stiffness Index)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Description: Composite metric integrating blood pressure and circumferential strain to quantify vascular stiffness. Calculation: β 2= ln(Systolic Blood Pressure/Diastolic Blood Pressure)/CS Data Sources: Blood pressure (non-invasive monitoring) + STI-derived CS.
7 secondary outcomes
Carotid Artery Elasticity (β1 Stiffness Index)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Systolic Diameter (Ds)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Diastolic Diameter (Dd)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery Peak Systolic Velocity (PSV)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
Carotid Artery End-Diastolic Velocity (EDV)
Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion
ICU Length of Stay
Time frame: up to 28 days
28-Day All-Cause Mortality
Time frame: Day 28 post-enrollment
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 8 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Shenfu Injection in people with Septic Shock and Vascular Dysfunction, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
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: opening soon, as of the sponsor's last update on 8 Apr 2025. 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 China. 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?
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 Qiancheng Xu (86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid Artery Circumferential Strain (CS) (time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion). The study lists 2 primary outcomes in all. 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 8 Apr 2025.