Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Anhui
-
Wuhu、Anhui、中国、241001
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
-
コンタクト：
- qiancheng xu, PhD
- メール：xu19871011@163.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Cardiac Index (CI)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-ICU02
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。