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Completed

NCT Number: NCT07162857

Guiding Fluid Resuscitation in Septic Shock: Ultrasound vs. Noninvasive Cardiac Output Monitoring

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panyu Central Hospital Affiliated to Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

non-invasive cardiac output monitoring

Device

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.

Ultrasonic technology

Device

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.

Primary outcomes

  1. 28-day mortality rate

    Time frame: 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.

  2. 28-Day Survival

    Time frame: 28 days from enrollment

    Proportion of patients who survive at 28 days after enrollment.

Secondary outcomes

  1. ICU hospitalization time

    Time frame: 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.

  2. Use of Mechanical Ventilation

    Time frame: From enrollment to the end of treatment at 4 weeks

    Proportion of patients requiring invasive mechanical ventilation during hospitalization.

  3. Duration of Mechanical Ventilation

    Time frame: From enrollment to the end of treatment at 4 weeks

    Number of days of invasive mechanical ventilation among patients who required ventilatory support.

  4. Use of Vasopressor Therapy

    Time frame: From enrollment to the end of treatment at 4 weeks

    Proportion of patients requiring vasopressor therapy (e.g., norepinephrine, dopamine).

  5. Time to Achieve Mean Arterial Pressure ≥65 mmHg

    Time frame: Within the first 6 hours after enrollment

    Time in minutes required from enrollment to reach a mean arterial pressure ≥65 mmHg.

  6. Incidence of Pulmonary Edema

    Time frame: Within 28 days after enrollment

    Proportion of patients who develop pulmonary edema during hospitalization.

  7. Proportion of Patients With Lactate Reduction ≥20% From Baseline

    Time frame: Within the first 6 hours after enrollment

    Percentage of patients whose serum lactate level decreased by ≥20% compared with baseline.

  8. Proportion of Patients With Lactate Clearance ≥10%

    Time frame: Within the first 6 hours after enrollment

    Percentage of patients achieving lactate clearance ≥10% from baseline.

  9. Incidence of Acute Kidney Injury (AKI)

    Time frame: Within 28 days after enrollment

    Proportion of patients who develop acute kidney injury, defined according to KDIGO criteria.

  10. Incidence of Acute Respiratory Distress Syndrome (ARDS)

    Time frame: Within 28 days after enrollment

    Proportion of patients who develop ARDS during hospitalization, defined according to the Berlin definition.

Sponsors and collaborators

Lead sponsor

Mai Xiaowei

Other

Collaborators

  • Guangzhou Panyu Central Hospital

Registry information

Official study title

The Value of Critical Care Ultrasound and Noninvasive Cardiac Output Monitoring in Guiding Fluid Resuscitation for Septic Shock in the Emergency Department

Acronym: CUS-NICOM-SS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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