Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Inferior vena cava collapsibility index
研究概览
简要总结
43 patients between 18-60 years presenting with criteria of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection, suspected or documented infection and an acute increase ≥2 SOFA [Sequential Organ Failure Assessment] points) will be enrolled in our study. Approval of the ethical committee and informed written consent from first degree relatives will be issued. They will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects.
To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .
详细描述
One of the newer non-invasive methods used to assess fluid status has been the IVC collapsibility index (IVC CI) - which has shown encouraging results as a guide to fluid therapy. Studies have shown that there is an increase in CVP and decrease in IVC collapsibility with fluid replacement, as well as that both are affected by changes in intrathoracic pressure and right heart dysfunction.
measurement of (IVC CI) is calculated by ultrasound through maximum IVC diameter - minimum IVC diameter divided by minimum diameter then multiplied by 100.
if it is less than 50% means that the patient is volume non- depleted while if it is more than 50% means the reverse.
The other recent non-invasive monitoring tool is electrical cardiometry. Its idea is based on electrical impedance. The variations in impedance are calculated using an algorithm that allows measurement of the CO as well as other key haemodynamic parameters including preload (Thoracic Fluid Index), afterload (systemic vascular resistance, SVR). This has helped provide a sound guide to each individual patient's response to fluid therapy and selection of the proper cardiovascular medications and support.
To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA class I and II
- •18yrs ≥ Age ≤ 60yrs
- •Fulfilling criteria of sepsis, as per The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
排除标准
- •Lack of consent
- •Active bleeding
- •Age < 18yrs or > 60yrs
- •Anticipated surgery or dialysis in the next 8hrs
- •Aortic regurge
- •Arrythmias
- •Cardiac tamponade
- •Chest wall oedema
- •Child B and Child C hepatic patients
- •Congestive heart failure
- •End-stage kidney disease (ESKD) patients with a creatinine clearance (CrCl) <50ml/min
- •Massive bilateral pleural effusion
- •Mechanical ventilation
- •More than 4hrs after meeting criteria of septic shock
- •New York Heart Association (NYHA) III and IV cardiac patients
- •Severe ARDS (acute respiratory distress syndrome)
- •Tense ascites
- •Vasopressor infusion (before or after inclusion in the study)
研究组 & 干预措施
Non-invasive cardiometry
OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others.
The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.
干预措施: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 (Device)
Non-invasive cardiometry
OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others.
The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.
干预措施: Fujifilm Sonosite M-Turbo C Ultrasound system (Device)
结局指标
主要结局
Inferior vena cava collapsibility index
时间窗: 6 hours
The ultrasound guided IVC collapsibility index will be correlated with to the cardiac index determined by the non-invasive cardiometry to determine which is more effective.
次要结局
- Heart rate(6 hours)
- Mean Arterial Pressure(6 hours)
- Central Venous Pressure(6 hours)
- Lactate clearance(6 hours)
- Pro-calcitonin(6 hours)
- Non-invasive cardiometry measurements (cardiac index)(6 hours)
- Urine Output(6 hours)
- Inferior Vena Cava Collapsibility Index(6 hours)
研究者
Mohamed Ahmed Abdellatif Hassan Gaafar
Principal Investigator
National Cancer Institute, Egypt