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临床试验/NCT07698834
NCT07698834尚未招募不适用

Splanchnic Perfusion Monitoring Using Doppler Ultrasound in Septic Shock Patients: Correlation With Lactate Clearance, Organ Dysfunction, and Enteral Feeding Intolerance

Assiut University0 个研究点目标入组 80 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Association between portal vein PF and SOFA progression

研究概览

简要总结

evaluation whether splanchnic Doppler ultrasound indices (SMA resistive index, portal vein pulsatility fraction, hepatic artery resistive index/flow parameters) can:

  1. Reflect regional tissue perfusion in septic shock, as correlated with lactate clearance.
  2. Associate with organ dysfunction severity and progression (SOFA dynamics).
  3. Predict enteral feeding intolerance in ICU patients receiving enteral nutrition

详细描述

Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to severe organ dysfunction. Globally, sepsis accounts for approximately 48.9 million cases and 11 million deaths annually.

A central clinical challenge is hemodynamic incoherence, where systemic targets (e.g., mean arterial pressure [MAP]) may improve while regional tissue perfusion remains impaired. Conventional systemic markers, including blood lactate clearance and central venous oxygen saturation, reflect global metabolic status and may lag behind microvascular dysfunction within specific organ beds.

The hepatosplanchnic circulation is particularly vulnerable during septic shock and may contribute to progression toward multiple organ failure through a sustained inflammatory cascade. The splanchnic region has been described as the "motor" of multiple organ failure and the "canary" of the body.

Bedside Doppler ultrasound has emerged as a noninvasive tool to assess regional perfusion. Doppler-derived indices such as the resistive index (and related parameters including portal pulsatility fraction) may detect early hemodynamic impairment at the organ-bed level before systemic biomarkers change.

Accordingly, improved bedside perfusion monitoring especially for the splanchnic circulation-may help optimize resuscitation strategy and nutritional management, and may clarify relationships between regional perfusion, organ dysfunction, and enteral feeding tolerance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Adult patients (≥18 years).
  • ICU admission with septic shock (Sepsis-3 definitions).

排除标准

  • Advanced chronic liver disease.
  • Portal vein thrombosis.
  • Mesenteric ischemia (or clinical suspicion strongly suggesting it).
  • Severe right-sided heart failure.
  • Morbid obesity or any condition causing poor/unsafe ultrasound acoustic window.
  • 7. Intra-abdominal conditions preventing adequate Doppler assessment.
  • Limitation of care / do-not-resuscitate orders.
  • Pre-existing major gastrointestinal bleeding/obstruction if that is relevant to enteral feeding intolerance outcomes in your ICU.

结局指标

主要结局

Association between portal vein PF and SOFA progression

时间窗: baseline through 72 hours after ICU admission

To evaluate the association between portal vein pulsatility fraction and progression in the Sequential Organ Failure Assessment (SOFA) score, defined as the difference between the baseline SOFA score and the SOFA score at 24 hours, or the peak SOFA score within 72 hours after ICU admission. The SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction and a worse clinical outcome.

Lactate clearance (%) at 6 and 24 hours after ICU admission

时间窗: baseline through 24 hours after ICU admission

Lactate clearance, expressed as a percentage (%), calculated from serial arterial blood lactate concentrations measured at baseline, 6 hours, and 24 hours after ICU admission. Blood lactate concentration will be measured using standard arterial blood gas/laboratory analysis. The correlation between the baseline superior mesenteric artery (SMA) resistive index measured by Doppler ultrasound and lactate clearance at 6 and 24 hours will be evaluated.

Incidence of enteral feeding intolerance within 72 hours after ICU admission

时间窗: within 72 hours after ICU admission

Incidence (%) of enteral feeding intolerance occurring within 72 hours after ICU admission, assessed according to predefined clinical criteria (e.g., vomiting, abdominal distension, or interruption of enteral nutrition due to intolerance). Superior mesenteric artery resistive index (SMA RI), portal vein pulsatility fraction (PVPF), and hepatic artery resistive index (HARI), measured by Doppler ultrasound at 24 hours after ICU admission, will be correlated with the occurrence of enteral feeding intolerance.

次要结局

  • Length of ICU Stay(From ICU admission until ICU discharge)
  • Duration of Vasopressor Therapy(From ICU admission until discontinuation of vasopressor therapy)
  • ICU Mortality(From ICU admission until ICU discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa Tarek Mahmoud Ahmed

specialist

Assiut University

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