Panyu Central Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
NCT Number: NCT07162857
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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All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Excluded criteria:
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.
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.
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.
Time frame: 28 days from enrollment
Proportion of patients who survive at 28 days after enrollment.
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Proportion of patients requiring invasive mechanical ventilation during hospitalization.
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Proportion of patients requiring vasopressor therapy (e.g., norepinephrine, dopamine).
Time frame: Within the first 6 hours after enrollment
Time in minutes required from enrollment to reach a mean arterial pressure ≥65 mmHg.
Time frame: Within 28 days after enrollment
Proportion of patients who develop pulmonary edema during hospitalization.
Time frame: Within the first 6 hours after enrollment
Percentage of patients whose serum lactate level decreased by ≥20% compared with baseline.
Time frame: Within the first 6 hours after enrollment
Percentage of patients achieving lactate clearance ≥10% from baseline.
Time frame: Within 28 days after enrollment
Proportion of patients who develop acute kidney injury, defined according to KDIGO criteria.
Time frame: Within 28 days after enrollment
Proportion of patients who develop ARDS during hospitalization, defined according to the Berlin definition.
Mai Xiaowei
Other
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
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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