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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-Z04-020 | Other Grant/Funding Number | Guangzhou Panyu District Science and Technology Program Project | |
| PYRC-2023-088 | Other Identifier | Medical Ethics Committee of Panyu Central Hospital |
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| Name | Class |
|---|---|
| Guangzhou Panyu Central Hospital | OTHER |
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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.
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days from enrollment |
| 28-Day Survival | Proportion of patients who survive at 28 days after enrollment. | 28 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| ICU hospitalization time | Number of days each patient remains in the intensive care unit (ICU) during the study period. | From enrollment to the end of treatment at 4 weeks |
| Use of Mechanical Ventilation |
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Inclusion criteria:
Excluded criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yingshen wen | Guangzhou Panyu Central Hospital, Guangzhou, Guangdong , China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panyu Central Hospital Affiliated to Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2023 | Sep 16, 2025 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2023 | Aug 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| 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. |
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Proportion of patients requiring invasive mechanical ventilation during hospitalization.
| 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. | From enrollment to the end of treatment at 4 weeks |
| Use of Vasopressor Therapy | Proportion of patients requiring vasopressor therapy (e.g., norepinephrine, dopamine). | 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. | Within the first 6 hours after enrollment |
| Incidence of Pulmonary Edema | Proportion of patients who develop pulmonary edema during hospitalization. | 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. | Within the first 6 hours after enrollment |
| Proportion of Patients With Lactate Clearance ≥10% | Percentage of patients achieving lactate clearance ≥10% from baseline. | 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. | 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. | Within 28 days after enrollment |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |