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临床试验/NCT07516236
NCT07516236尚未招募不适用

Diagnostic Accuracy of Dynamic Central Venous Oxygen Saturation in Predicting Fluid Responsiveness in Septic Shock: A Prospective Observational Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2026年8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
115
试验地点
1
主要终点
Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge.

研究概览

简要总结

This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.

详细描述

All patients will undergo standardized monitoring to ensure accurate and reproducible hemodynamic assessment throughout the study period.

Blood pressure will be monitored noninvasively using an automated oscillometric cuff applied to the upper arm. MAP will be maintained at ≥65 mmHg with vasopressor support as required, and no changes in vasopressor infusion will be permitted during the measurement period.

A central venous catheter will be inserted in the internal jugular or subclavian vein, with the position confirmed by chest radiography. Central venous blood samples will be collected at baseline and after the fluid challenge for the determination of a Central venous oxygen saturation (ScvO₂).

Echocardiographic Assessment Left ventricular outflow tract (LVOT) diameter will be measured in the parasternal long-axis view by transthoracic echocardiography (Sonoscape S8 Echocardiography), and Doppler assessment of velocity- time integral (VTI) will be obtained in the apical five-chamber view. Stroke volume (SV) will be calculated as LVOT area × VTI, and values will be averaged from three consecutive cardiac cycles over a single respiratory cycle. The echocardiography operator will be an expert intensivist in echo operation (more than 7 years of experience), and the operator will be blinded to ScvO2.

Cardiac Output Monitoring (Electrical Cardiometry) Cardiac output will also be assessed noninvasively using a validated electrical cardiometry device (ICON®, Osypka Medical, Germany).

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

  • Age > 18 years
  • Diagnosis of septic shock according to Sepsis-3 criteria:
  • Suspected or confirmed infection o Requirement for vasopressors to maintain MAP > 65 mmHg o Serum lactate > 2 mmol/L despite adequate fluid resuscitation

排除标准

  • Pregnancy
  • Significant valvular heart disease.
  • Atrial fibrillation.
  • Inadequate echocardiographic window.
  • Ongoing bleeding or contraindication to fluid bolus.

结局指标

主要结局

Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge.

时间窗: After 30 mins

次要结局

  • Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.(After 30 mins)

研究者

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

Nevine Mostafa Soliman

Assistant Professor

Menoufia University

研究点 (1)

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