Septic Shock
Conditions
Keywords
critical care ultrasound, noninvasive cardiac output monitoring, eptic shock, fluid resuscitation
Brief summary
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.
Detailed description
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).
Interventions
Monitoring commenced immediately after enrollment, with baseline parameters recorded after signal stabilization (≤5 minutes), including cardiac output (CO), stroke volume (SV), stroke volume variation (SVV), and systemic vascular resistance (SVR). The system automatically updated these parameters every 30 seconds and displayed them in real-time on the monitor screen. Fluid resuscitation was dynamically adjusted according to these continuous measurements until achieving the predefined therapeutic targets.
DEVICEUltrasonic technology
In the critical care ultrasound group, patients underwent immediate bedside This protocol ensured real-time, comprehensive evaluation of both cardiac function and fluid status to guide resuscitation.Ultrasound reassessment was performed every 1-2 hours to dynamically adjust both the volume and rate of fluid administration until predefined resuscitation targets were achieved.
Sponsors
Guangzhou Panyu Central Hospital
Mai Xiaowei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosis of septic shock in accordance with the Surviving Sepsis Campaign International ; 2. receipt of initial fluid resuscitation in the emergency department with a hospital stay of at least 6 hours; 3. age ≥ 18 years; 4. provision of informed consent. Excluded criteria: 1. contraindications to rapid fluid administration (e.g., end-stage renal disease, end-stage heart failure, acute pulmonary edema); 2. inability to comply with treatment, such as patients with severe trauma, burns, cancer undergoing chemotherapy, pregnant or lactating women, and those with mental illness; 3. withdrawal from treatment or transfer to another facility within 24 hours of admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality rate | 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 | 28 days from enrollment | Proportion of patients who survive at 28 days after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | From enrollment to the end of treatment at 4 weeks | Number of days of invasive mechanical ventilation among patients who required ventilatory support. |
| Use of Vasopressor Therapy | From enrollment to the end of treatment at 4 weeks | Proportion of patients requiring vasopressor therapy (e.g., norepinephrine, dopamine). |
| Time to Achieve Mean Arterial Pressure ≥65 mmHg | Within the first 6 hours after enrollment | Time in minutes required from enrollment to reach a mean arterial pressure ≥65 mmHg. |
| Incidence of Pulmonary Edema | Within 28 days after enrollment | Proportion of patients who develop pulmonary edema during hospitalization. |
| ICU hospitalization time | From enrollment to the end of treatment at 4 weeks | Number of days each patient remains in the intensive care unit (ICU) during the study period. |
| Proportion of Patients With Lactate Clearance ≥10% | Within the first 6 hours after enrollment | Percentage of patients achieving lactate clearance ≥10% from baseline. |
| Incidence of Acute Kidney Injury (AKI) | Within 28 days after enrollment | Proportion of patients who develop acute kidney injury, defined according to KDIGO criteria. |
| Incidence of Acute Respiratory Distress Syndrome (ARDS) | Within 28 days after enrollment | Proportion of patients who develop ARDS during hospitalization, defined according to the Berlin definition. |
| Proportion of Patients With Lactate Reduction ≥20% From Baseline | Within the first 6 hours after enrollment | Percentage of patients whose serum lactate level decreased by ≥20% compared with baseline. |
| Use of Mechanical Ventilation | From enrollment to the end of treatment at 4 weeks | Proportion of patients requiring invasive mechanical ventilation during hospitalization. |
Countries
China
Outcome results
None listed