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Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock

18 maggio 2026 aggiornato da: Qiancheng Xu, First Affiliated Hospital of Wannan Medical College

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Anhui
      • Wuhu, Anhui, Cina, 241001
        • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Shenfu Injection Group

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.
Droga: Shenfu Injection

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])
Lasso di tempo: 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.
Baseline and 3 hours after infusion

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Cardiac Index (CI)
Lasso di tempo: Baseline and 3 hours after infusion

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.
Baseline and 3 hours after infusion
Change in Stroke Index (SI)
Lasso di tempo: Baseline and 3 hours after infusion

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.
Baseline and 3 hours after infusion
Change in Systemic Vascular Resistance Index (RIs)
Lasso di tempo: Baseline and 3 hours after infusion.
Calculated as (MAP - CVP)/CI (unit: mmHg · min · m²/L).
Baseline and 3 hours after infusion.
Change in Critical Closure Pressure (Pcc)
Lasso di tempo: Baseline and 3 hours after infusion.

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.
Baseline and 3 hours after infusion.
Change in Mean Systemic Filling Pressure (Pmsf)
Lasso di tempo: Baseline and 3 hours after infusion.

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.
Baseline and 3 hours after infusion.
Change in Central Venous Oxygen Saturation (ScvO₂)
Lasso di tempo: Baseline and 3 hours after infusion.

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.
Baseline and 3 hours after infusion.
Change in Arterial-Venous CO₂ Difference (Pcv-aCO₂)
Lasso di tempo: Baseline and 3 hours after infusion.

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.
Baseline and 3 hours after infusion.
Change in Blood Lactate Concentration
Lasso di tempo: Baseline and 3 hours after infusion.

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.
Baseline and 3 hours after infusion.
Change in Norepinephrine Dosage Requirement
Lasso di tempo: Baseline and 3 hours after infusion.

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.
Baseline and 3 hours after infusion.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

First Affiliated Hospital of Wannan Medical College

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 maggio 2027

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-ICU02

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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