The Value of Critical Care Ultrasound and Noninvasive Cardiac Output Monitoring in Guiding Fluid Resuscitation for Septic Shock in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 28-day mortality rate
研究概览
简要总结
This randomized controlled study investigates the value of critical care ultrasound and non-invasive cardiac output monitoring in guiding fluid resuscitation for patients with septic shock in the emergency department. A total of 60 patients are randomly assigned to receive either ultrasound-guided or NICOM-guided fluid management, with both groups receiving standard sepsis care according to the 2021 Surviving Sepsis Campaign guidelines.
The study aims to evaluate whether these monitoring modalities can optimize hemodynamic management, improve prognosis, and support clinical decision-making in emergency settings. Primary and secondary outcomes include early resuscitation efficacy (time to achieve mean arterial pressure ≥65 mmHg and lactate clearance), total fluid volume within the first 6 hours, incidence of complications (pulmonary edema, renal injury, ARDS), length of stay in the emergency department and hospital, and 28-day mortality.
By comparing these two approaches, this study seeks to provide evidence for selecting appropriate monitoring tools to achieve precise and individualized fluid resuscitation in septic shock.
详细描述
This study is a prospective randomized controlled trial conducted in the Emergency Department of Guangzhou Panyu Central Hospital. Eligible adult patients with septic shock, admitted between july 2023 and july 2025, were enrolled after informed consent. Demographic and baseline clinical data, including age, gender, comorbidities, mean arterial pressure, baseline lactate, and vital signs, were collected at enrollment.
A total of 60 patients were randomly assigned to one of two intervention groups using block randomization generated by SPSS software, with allocation concealed by sealed envelopes.
- Critical Care Ultrasound Group: Patients underwent bedside ultrasound assessment, including inferior vena cava diameter and collapsibility index (IVC-CI), left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), ventricular wall motion, and pulmonary B-lines, to guide individualized fluid resuscitation. Ultrasound evaluations were repeated every 1-2 hours until resuscitation targets were achieved.
- Non-Invasive Cardiac Output Monitoring (NICOM) Group: Patients received continuous hemodynamic monitoring using thoracic bioreactance technology. Parameters including cardiac output (CO), stroke volume (SV), stroke volume variation (SVV), and systemic vascular resistance (SVR) were continuously recorded and used to guide fluid therapy adjustments until resuscitation targets were achieved.
In both groups, all patients received standard septic shock management based on the 2021 Surviving Sepsis Campaign guidelines, including early antibiotics, vasopressor therapy, and organ support. Outcomes recorded included total fluid volume within the first 6 hours, time to resuscitation targets, complications (e.g., pulmonary edema, renal injury, ARDS), emergency department and hospital length of stay, 28-day mortality, and adverse events (e.g., arrhythmias, anaphylaxis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of septic shock in accordance with the Surviving Sepsis Campaign International ;
- •receipt of initial fluid resuscitation in the emergency department with a hospital stay of at least 6 hours;
- •age ≥ 18 years;
- •provision of informed consent.
- •Excluded criteria:
- •contraindications to rapid fluid administration (e.g., end-stage renal disease, end-stage heart failure, acute pulmonary edema);
- •inability to comply with treatment, such as patients with severe trauma, burns, cancer undergoing chemotherapy, pregnant or lactating women, and those with mental illness;
- •withdrawal from treatment or transfer to another facility within 24 hours of admission.
排除标准
- 未提供
研究组 & 干预措施
Critical Care Ultrasound Group
patients underwent immediate bedside assessment using a Philips EPIQ 5 color Doppler ultrasound system equipped with both phased-array (1.5-4.0 MHz) and convex-array (2.0-5.0 MHz) transducers. The initial ultrasound evaluation was completed within 10 minutes of enrollment and included comprehensive hemodynamic monitoring: inferior vena cava diameter (IVC) and collapsibility index (IVC-CI) for volume status assessment, left ventricular ejection fraction (LVEF) and end-diastolic volume (LVEDV) for cardiac function evaluation, ventricular wall motion analysis, along with pulmonary B-line quantification to assess pulmonary edema.
干预措施: Ultrasonic technology (Device)
Non-Invasive Cardiac Output Monitoring (NICOM) Group
In the noninvasive cardiac output monitoring group, continuous hemodynamic assessment was performed using the NICOM system based on thoracic bioreactance technology.
干预措施: non-invasive cardiac output monitoring (Device)
结局指标
主要结局
28-day mortality rate
时间窗: 28 days from enrollment
Proportion of patients who die within 28 days after enrollment. Mortality will be assessed using hospital records and survival follow-up.
28-Day Survival
时间窗: 28 days from enrollment
Proportion of patients who survive at 28 days after enrollment.
次要结局
- Duration of Mechanical Ventilation(From enrollment to the end of treatment at 4 weeks)
- ICU hospitalization time(From enrollment to the end of treatment at 4 weeks)
- Use of Mechanical Ventilation(From enrollment to the end of treatment at 4 weeks)
- Use of Vasopressor Therapy(From enrollment to the end of treatment at 4 weeks)
- Time to Achieve Mean Arterial Pressure ≥65 mmHg(Within the first 6 hours after enrollment)
- Incidence of Pulmonary Edema(Within 28 days after enrollment)
- Proportion of Patients With Lactate Reduction ≥20% From Baseline(Within the first 6 hours after enrollment)
- Proportion of Patients With Lactate Clearance ≥10%(Within the first 6 hours after enrollment)
- Incidence of Acute Kidney Injury (AKI)(Within 28 days after enrollment)
- Incidence of Acute Respiratory Distress Syndrome (ARDS)(Within 28 days after enrollment)
研究者
Mai Xiaowei
Emergency Department Attending Physician，Guangzhou Panyu Central Hospital
Guangzhou Panyu Central Hospital