Septic ShockCUS-NICOM-SSNCT07162857
Guiding Fluid Resuscitation in Septic Shock: Ultrasound vs. Noninvasive Cardiac Output Monitoring
A study testing non-invasive cardiac output monitoring and Ultrasonic technology in people with Septic Shock, run by Mai Xiaowei at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- non-invasive cardiac output monitoring and Ultrasonic technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Panyu Central Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: The Value of Critical Care Ultrasound and Noninvasive Cardiac Output Monitoring in Guiding Fluid Resuscitation for Septic Shock in the Emergency Department
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.
Read the 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).
- Conditions
- Septic Shock
- Being tested
- non-invasive cardiac output monitoring, Ultrasonic technology
- Keywords
- critical care ultrasound, noninvasive cardiac output monitoring, eptic shock, fluid resuscitation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive cardiac output monitoringDevice
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 technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Critical Care Ultrasound Group | Experimental | 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. Receives: Device: Ultrasonic technology |
| Non-Invasive Cardiac Output Monitoring (NICOM) Group | Experimental | In the noninvasive cardiac output monitoring group, continuous hemodynamic assessment was performed using the NICOM system based on thoracic bioreactance technology. Receives: Device: non-invasive cardiac output monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality rate
Proportion of patients who die within 28 days after enrollment. Mortality will be assessed using hospital records and survival follow-up.
Measured: 28 days from enrollment
28-Day Survival
Proportion of patients who survive at 28 days after enrollment.
Measured: 28 days from enrollment
Secondary outcomes (10)
ICU hospitalization time
Number of days each patient remains in the intensive care unit (ICU) during the study period.
Measured: From enrollment to the end of treatment at 4 weeks
Use of Mechanical Ventilation
Proportion of patients requiring invasive mechanical ventilation during hospitalization.
Measured: From enrollment to the end of treatment at 4 weeks
Duration of Mechanical Ventilation
Number of days of invasive mechanical ventilation among patients who required ventilatory support.
Measured: From enrollment to the end of treatment at 4 weeks
Use of Vasopressor Therapy
Proportion of patients requiring vasopressor therapy (e.g., norepinephrine, dopamine).
Measured: From enrollment to the end of treatment at 4 weeks
Time to Achieve Mean Arterial Pressure ≥65 mmHg
Time in minutes required from enrollment to reach a mean arterial pressure ≥65 mmHg.
Measured: Within the first 6 hours after enrollment
Incidence of Pulmonary Edema
Proportion of patients who develop pulmonary edema during hospitalization.
Measured: Within 28 days after enrollment
Proportion of Patients With Lactate Reduction ≥20% From Baseline
Percentage of patients whose serum lactate level decreased by ≥20% compared with baseline.
Measured: Within the first 6 hours after enrollment
Proportion of Patients With Lactate Clearance ≥10%
Percentage of patients achieving lactate clearance ≥10% from baseline.
Measured: Within the first 6 hours after enrollment
Incidence of Acute Kidney Injury (AKI)
Proportion of patients who develop acute kidney injury, defined according to KDIGO criteria.
Measured: Within 28 days after enrollment
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Proportion of patients who develop ARDS during hospitalization, defined according to the Berlin definition.
Measured: Within 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start5 Jul 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mai Xiaowei
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Panyu Central Hospital
- Responsible party
- Sponsor-investigator, Mai Xiaowei, Guangzhou Panyu Central Hospital
- Investigators
- yingshen wen, Principal investigator, Guangzhou Panyu Central Hospital, Guangzhou, Guangdong , China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162857
- Sponsor's protocol ID
- PYRC-2023-088
- Other IDs
- 2024-Z04-020, PYRC-2023-088
- Acronym
- CUS-NICOM-SS
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Critical Care Ultrasound and Noninvasive Cardiac Output Monitoring in Guiding Fluid Resuscitation for Septic Shock in the Emergency Department
- ClinicalTrials.gov ID
- NCT07162857
- Acronym / sponsor ID
- CUS-NICOM-SS / PYRC-2023-088
- Conditions
- Septic Shock
- Keywords
- critical care ultrasound, noninvasive cardiac output monitoring, eptic shock, fluid resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mai XiaoweiUniversity, hospital or other
- Collaborators
- Guangzhou Panyu Central Hospital
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical Care Ultrasound Group | Experimental | Device: Ultrasonic technologypatients 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. |
| Non-Invasive Cardiac Output Monitoring (NICOM) Group | Experimental | Device: non-invasive cardiac output monitoringIn the noninvasive cardiac output monitoring group, continuous hemodynamic assessment was performed using the NICOM system based on thoracic bioreactance technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- contraindications to rapid fluid administration (e.g., end-stage renal disease, end-stage heart failure, acute pulmonary edema);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive cardiac output monitoringMonitoring 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. | Device | Non-Invasive Cardiac Output Monitoring (NICOM) Group |
| Ultrasonic technologyIn 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. | Device | Critical Care Ultrasound Group |
Primary outcome
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.
28-Day Survival
Time frame: 28 days from enrollment
Proportion of patients who survive at 28 days after enrollment.
10 secondary outcomes
ICU hospitalization time
Time frame: From enrollment to the end of treatment at 4 weeks
Use of Mechanical Ventilation
Time frame: From enrollment to the end of treatment at 4 weeks
Duration of Mechanical Ventilation
Time frame: From enrollment to the end of treatment at 4 weeks
Use of Vasopressor Therapy
Time frame: From enrollment to the end of treatment at 4 weeks
Time to Achieve Mean Arterial Pressure ≥65 mmHg
Time frame: Within the first 6 hours after enrollment
Incidence of Pulmonary Edema
Time frame: Within 28 days after enrollment
Proportion of Patients With Lactate Reduction ≥20% From Baseline
Time frame: Within the first 6 hours after enrollment
Proportion of Patients With Lactate Clearance ≥10%
Time frame: Within the first 6 hours after enrollment
Incidence of Acute Kidney Injury (AKI)
Time frame: Within 28 days after enrollment
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Time frame: Within 28 days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yingshen wen principal investigator
Guangzhou Panyu Central Hospital, Guangzhou, Guangdong , China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive cardiac output monitoring and Ultrasonic technology in people with Septic Shock, run by Mai Xiaowei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality rate (time frame: 28 days from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.