Guiding Fluid Resuscitation in Septic Shock: Ultrasound vs. Noninvasive Cardiac Output Monitoring (CUS-NICOM-SS)

Mai Xiaowei

Status: Completed

Conditions: Septic Shock

Treatments: Device: Ultrasonic technology; Device: non-invasive cardiac output monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07162857

PYRC-2023-088 (Other Identifier)

2024-Z04-020 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Critical Care Ultrasound Group

Experimental group

Description:

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.

Treatment:

Device: Ultrasonic technology

Non-Invasive Cardiac Output Monitoring (NICOM) Group

Experimental group

Description:

In the noninvasive cardiac output monitoring group, continuous hemodynamic assessment was performed using the NICOM system based on thoracic bioreactance technology.

Treatment:

Device: non-invasive cardiac output monitoring