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

NCT07162857 | Completed DMC

• 2 other identifiers: PYRC-2023-0882024-Z04-020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Septic Shock

Keywords

critical care ultrasound; noninvasive cardiac output monitoring; eptic shock; fluid resuscitation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• ICU hospitalization time

  From enrollment to the end of treatment at 4 weeks

• Use of Mechanical Ventilation

  From enrollment to the end of treatment at 4 weeks

• Duration of Mechanical Ventilation

  From enrollment to the end of treatment at 4 weeks

• Use of Vasopressor Therapy

  From enrollment to the end of treatment at 4 weeks

• Time to Achieve Mean Arterial Pressure ≥65 mmHg

  Within the first 6 hours after enrollment

Study Arms (2)

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.

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.

Device: non-invasive cardiac output monitoring

Interventions

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.

Non-Invasive Cardiac Output Monitoring (NICOM) Group

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.

Critical Care Ultrasound Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Mai Xiaowei: lead
• Guangzhou Panyu Central Hospital: collaborator

Study Sites (1)

Panyu Central Hospital Affiliated to Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• yingshen wen

  Guangzhou Panyu Central Hospital, Guangzhou, Guangdong , China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emergency Department Attending Physician，Guangzhou Panyu Central Hospital

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 9, 2025
• Study Start: July 5, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CN (1)