Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock (NCT07603024) | Clinical Trial Compass
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Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock
China20 participantsStarted 2026-07-01
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])
Timeframe: Baseline and 3 hours after infusion
Trial details
NCT IDNCT07603024
SponsorFirst Affiliated Hospital of Wannan Medical College