Comparing the Non Invasive Cardiometry With Ultrasound Guided Inferior Vena Cava Collapsibility for Evaluation of Fluid Responsiveness in Septic Patient; Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fluid responsiveness
研究概览
简要总结
The study aims to evaluate the accuracy of fluid responsiveness assessment with non-invasive cardiometry compared to ultrasound guided inferior vena cava (IVC) collapsibility for management of critically ill septic patients with hemodynamic instability.
详细描述
Prospective Randomized observational comparative single blinded study will be conducted at intensive care unit at Benha University Hospitals after obtaining approval of the ethical committee and informed written consent from first degree relatives will be issued. The blindness will be performed to the patients.
The study will be conducted according to CONSORT 2010 statement. Enrolment of eligible patients will occur within 8 h of meeting the criteria for septic shock. All patients will be randomized using the computer-generated software of randomization and sealed closed envelopes to allocate them to one of two groups (30 patients each). Routine measurements and investigations will be taken at admission to intensive care unit; history, vital signs, routine laboratory investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class I and II
- •Age 18-65 years old of both genders.
- •Fulfilment criteria of sepsis as defined according to the standard Surviving Sepsis Campaign criteria using the Sequential (sepsis-related) Organ Failure Assessment (SOFA) score (SOFA score ≥ 2 indicated organ dysfunction).
- •Patients within 8 h of meeting the criteria for septic shock.
排除标准
- •Lack of consent
- •Age below 18 and above 65 years old.
- •acute coronary syndrome
- •major cardiac dysrhythmia,
- •valvular or congenital heart disease
- •Massive bilateral pleural effusion
- •Severe anaemia
- •End-stage kidney disease (ESKD) patients with Creatinine clearance (CrCl) <50ml/min.
- •Child B and Child C hepatic patients
- •impaired systolic function according to the ejection fraction (EF) (EF < 40% indicated impaired systolic function)
- •Severe ARDS (acute respiratory distress syndrome).
- •Tense ascites
- •Mechanical ventilation.
结局指标
主要结局
Fluid responsiveness
时间窗: 2 years
The study primary outcome will be the cardiac index determined by the non-invasive cardiometry in correlation with ultrasound guided IVC collapsibility index to determine which is more effective in prediction of fluid responsiveness.
次要结局
- total infused fluid from ICU arrival till the goal is achieved(2 years)
- total dose of vasopressor and inotrope taken during ICU stay period(2 years)
- time to weaning of vasopressors and inotropes(2 years)
研究者
Ebtehal Shaheen
assisstant lecturer at faculty of medicine
Benha University