Septic ShockNCT07603024
Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock
A study testing Shenfu Injection in people with Septic Shock, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation. 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?
- Shenfu Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
nclusion Criteria Septic shock diagnosed according to Sepsis-3 criteria after adequate fluid resuscitation.
Age ≥ 18 years. Within 24 hours of ICU admission. Receiving norepinephrine ≥ 0.10 µg/kg/min to maintain mean arterial pressure ≥ 65 mmHg.
Hemodynamically stable without vasopressor dose adjustment for ≥ 30 minutes before baseline measurement.
Endotracheal intubation with controlled mechanical ventilation under continuous sedation and analgesia.
Presence of both arterial and central venous catheters with PiCCO monitoring capability.
Written informed consent obtained from the patient or legally authorized representative.
Exclusion Criteria Cardiogenic shock as primary diagnosis or cardiac index < 2.2 L/min/m² after optimization.
Severe pulmonary bullae, pneumothorax, or conditions precluding safe inspiratory hold maneuvers.
Pregnancy or lactation. Expected ICU stay < 48 hours or limitation of life-sustaining therapy. Known allergy or contraindication to Shenfu Injection or its ingredients (e.g., ginseng, aconitum).
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, 241001
qiancheng xu, PhD, xu19871011@163.com
About this study
Official title: Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective Pilot Study
This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation.
Eligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure.
This study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.
Read the detailed description
his prospective single-center interventional pilot study aims to evaluate the hemodynamic and microcirculatory effects of Shenfu Injection in septic shock patients, focusing on the vascular waterfall phenomenon quantified by Critical Closure Pressure (Pcc) and Mean Systemic Filling Pressure (Pmsf).
After achieving hemodynamic optimization according to Surviving Sepsis Campaign guidelines, qualified participants will receive a single intravenous infusion of 100 mL Shenfu Injection, diluted and administered over 1 hour. Hemodynamic and oxygen metabolism parameters will be recorded at baseline (within 30 minutes before infusion) and 3 hours after infusion.
Pcc and Pmsf will be determined using the inspiratory hold maneuver method via ventilator (plateau pressures of 5, 15, 25, and 35 cm H₂O). Ventricular Output (VO) and Venous Return (VR) curves will be constructed, and linear regression will yield intercepts representing Pcc and Pmsf.
The primary analysis will compare pre- and post-infusion Pcc-Pmsf differences to determine restoration or augmentation of the vascular waterfall phenomenon. Secondary parameters such as CI, SI, MAP, CVP, ScvO₂, Pcv-aCO₂, and blood lactate will be observed to evaluate overall circulatory and metabolic response.
- Conditions
- Septic Shock
- Being tested
- Shenfu Injection
- Keywords
- Shenfu Injection, Traditional Chinese Medicine, Septic Shock, Vascular Waterfall Phenomenon, Critical Closure Pressure, Intensive Care Unit
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenfu InjectionDrug
All participants in the study will receive a single intravenous infusion of Shenfu Injection, a traditional Chinese medicine produced by China Resources Sanjiu Pharmaceutical Co., Ltd. The injection contains extracts of Ginseng Radix et Rhizoma and Aconiti Lateralis Radix Praeparata.
Each dose consists of 100 mL Shenfu Injection, diluted in 250 mL normal saline, and administered through continuous intravenous infusion over 1 hour after initial hemodynamic stabilization according to Surviving Sepsis Campaign guidelines.
Hemodynamic measurements will be performed before infusion (within 30 minutes) and at 3 hours after infusion. Variables include critical closure pressure (Pcc), mean systemic filling pressure (Pmsf), cardiac index, systemic vascular resistance, central venous oxygen saturation, arterial-venous CO₂ difference, and blood lactate concentration.
No other investigational drugs, placebos, or control interventions are administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Shenfu Injection Group | Experimental | All enrolled patients with septic shock will receive a single intravenous infusion of Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.).
The drug dose is 100 mL, diluted in 250 mL of normal saline, infused over 1 hour after initial hemodynamic stabilization.
Hemodynamic and microcirculatory parameters are measured before infusion and 3 hours after infusion, including vascular waterfall difference (critical closure pressure minus mean systemic filling pressure) and related physiological variables.
No control or placebo arm is included in this study. Receives: Drug: Shenfu Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])
The difference between Pcc and Pmsf (in mmHg) measured via ventilator-induced inspiratory hold method during mechanical ventilation, representing presence and magnitude of vascular waterfall phenomenon.
Measured: Baseline and 3 hours after infusion
Secondary outcomes (9)
Change in Cardiac Index (CI)
Cardiac index (L/min/m²) represents cardiac output standardized by body surface area and indicates overall pump function.
CI will be measured continuously using the PiCCO hemodynamic monitoring system through arterial thermodilution.
Values before Shenfu Injection and 3 hours post-infusion will be compared to evaluate changes in cardiac performance.
Measured: Baseline and 3 hours after infusion
Change in Stroke Index (SI)
Stroke index (mL/m²) reflects the amount of blood ejected from the left ventricle per beat per body-surface area, used to assess stroke volume changes.
Measured using the PiCCO system and calculated automatically from thermodilution data.
Measured: Baseline and 3 hours after infusion
Change in Systemic Vascular Resistance Index (RIs)
Calculated as (MAP - CVP)/CI (unit: mmHg · min · m²/L).
Measured: Baseline and 3 hours after infusion.
Change in Critical Closure Pressure (Pcc)
Pcc (mmHg) is obtained by plotting ventricular output against mean arterial pressure during ventilator inspiratory hold maneuvers.
It represents the pressure below which small vessels collapse and microcirculatory flow ceases.
Analyzing Pcc before and after infusion will help assess whether Shenfu Injection modifies microvascular closing pressure.
Measured: Baseline and 3 hours after infusion.
Change in Mean Systemic Filling Pressure (Pmsf)
Pmsf (mmHg) is the theoretical pressure at zero venous flow reflecting venous capacitance and circulating volume.
It will be estimated from the venous return curve during inspiratory hold. Comparing values pre- and post-infusion will show any effect of Shenfu Injection on mean systemic pressure and stressed volume.
Measured: Baseline and 3 hours after infusion.
Change in Central Venous Oxygen Saturation (ScvO₂)
ScvO₂ (%) measures oxygen content in central venous blood and reflects balance between oxygen delivery and consumption.
Obtained from central venous blood gas analysis. An increase may indicate improved tissue oxygenation after treatment.
Measured: Baseline and 3 hours after infusion.
Change in Arterial-Venous CO₂ Difference (Pcv-aCO₂)
Pcv-aCO₂ (mmHg) is the difference between central venous and arterial partial pressures of CO₂, reflecting adequacy of cardiac output and tissue perfusion.
Measured simultaneously from arterial and central venous samples by blood gas analyzer.
Measured: Baseline and 3 hours after infusion.
Change in Blood Lactate Concentration
Blood lactate (mmol/L) is a biochemical marker of anaerobic metabolism and tissue hypoxia.
Measured from arterial blood gas. Reduction after infusion may indicate improvement in microcirculatory perfusion.
Measured: Baseline and 3 hours after infusion.
Change in Norepinephrine Dosage Requirement
Average norepinephrine infusion rate (µg/kg/min) required to maintain mean arterial pressure ≥ 65 mmHg will be recorded.
Decreased dose after infusion may suggest improved vasomotor tone or systemic perfusion.
Measured: Baseline and 3 hours after infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603024
- Sponsor's protocol ID
- 2026-ICU02
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07603024
- Acronym / sponsor ID
- 2026-ICU02
- Conditions
- Septic Shock
- Keywords
- Shenfu Injection, Traditional Chinese Medicine, Septic Shock, Vascular Waterfall Phenomenon, Critical Closure Pressure, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 May 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 prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation.
Eligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure.
This study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.
Detailed description
his prospective single-center interventional pilot study aims to evaluate the hemodynamic and microcirculatory effects of Shenfu Injection in septic shock patients, focusing on the vascular waterfall phenomenon quantified by Critical Closure Pressure (Pcc) and Mean Systemic Filling Pressure (Pmsf).
After achieving hemodynamic optimization according to Surviving Sepsis Campaign guidelines, qualified participants will receive a single intravenous infusion of 100 mL Shenfu Injection, diluted and administered over 1 hour. Hemodynamic and oxygen metabolism parameters will be recorded at baseline (within 30 minutes before infusion) and 3 hours after infusion.
Pcc and Pmsf will be determined using the inspiratory hold maneuver method via ventilator (plateau pressures of 5, 15, 25, and 35 cm H₂O). Ventricular Output (VO) and Venous Return (VR) curves will be constructed, and linear regression will yield intercepts representing Pcc and Pmsf.
The primary analysis will compare pre- and post-infusion Pcc-Pmsf differences to determine restoration or augmentation of the vascular waterfall phenomenon. Secondary parameters such as CI, SI, MAP, CVP, ScvO₂, Pcv-aCO₂, and blood lactate will be observed to evaluate overall circulatory and metabolic response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shenfu Injection Group | Experimental | Drug: Shenfu InjectionAll enrolled patients with septic shock will receive a single intravenous infusion of Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). The drug dose is 100 mL, diluted in 250 mL of normal saline, infused over 1 hour after initial hemodynamic stabilization. Hemodynamic and microcirculatory parameters are measured before infusion and 3 hours after infusion, including vascular waterfall difference (critical closure pressure minus mean systemic filling pressure) and related physiological variables. No control or placebo arm is included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 InjectionAll participants in the study will receive a single intravenous infusion of Shenfu Injection, a traditional Chinese medicine produced by China Resources Sanjiu Pharmaceutical Co., Ltd. The injection contains extracts of Ginseng Radix et Rhizoma and Aconiti Lateralis Radix Praeparata. Each dose consists of 100 mL Shenfu Injection, diluted in 250 mL normal saline, and administered through continuous intravenous infusion over 1 hour after initial hemodynamic stabilization according to Surviving Sepsis Campaign guidelines. Hemodynamic measurements will be performed before infusion (within 30 minutes) and at 3 hours after infusion. Variables include critical closure pressure (Pcc), mean systemic filling pressure (Pmsf), cardiac index, systemic vascular resistance, central venous oxygen saturation, arterial-venous CO₂ difference, and blood lactate concentration. No other investigational drugs, placebos, or control interventions are administered in this study. | Drug | Shenfu Injection Group |
Primary outcome
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])
Time frame: Baseline and 3 hours after infusion
The difference between Pcc and Pmsf (in mmHg) measured via ventilator-induced inspiratory hold method during mechanical ventilation, representing presence and magnitude of vascular waterfall phenomenon.
9 secondary outcomes
Change in Cardiac Index (CI)
Time frame: Baseline and 3 hours after infusion
Change in Stroke Index (SI)
Time frame: Baseline and 3 hours after infusion
Change in Systemic Vascular Resistance Index (RIs)
Time frame: Baseline and 3 hours after infusion.
Change in Critical Closure Pressure (Pcc)
Time frame: Baseline and 3 hours after infusion.
Change in Mean Systemic Filling Pressure (Pmsf)
Time frame: Baseline and 3 hours after infusion.
Change in Central Venous Oxygen Saturation (ScvO₂)
Time frame: Baseline and 3 hours after infusion.
Change in Arterial-Venous CO₂ Difference (Pcv-aCO₂)
Time frame: Baseline and 3 hours after infusion.
Change in Blood Lactate Concentration
Time frame: Baseline and 3 hours after infusion.
Change in Norepinephrine Dosage Requirement
Time frame: Baseline and 3 hours after infusion.
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 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shenfu Injection in people with Septic Shock, 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?
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 22 May 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf]) (time frame: Baseline and 3 hours after infusion). 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 22 May 2026.