Consistency of Fluid Tolerance Evaluation Methods and Their Correlation With Clinical Outcomes in Patients With Shock

Consistency of Fluid Tolerance Evaluation Methods and Their Correlation With Clinical Outcomes in Shock Patients:A Prospective, Observational Study

This study aims to explore the feasibility and scientific validity of carotid-jugular Doppler in evaluating volume tolerance in shock patients (with the VExUS score as an important reference standard), and to conduct an in-depth analysis of the correlation between its monitoring indicators and patient prognosis.The primary endpoint is comparison of the agreement between hands-free carotid-jugular Doppler and the VExUS score in evaluating volume tolerance.The secondary endpoint is correlation between volume tolerance assessed by hands-free carotid-jugular Doppler and the clinical outcomes of shock patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shock

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Zhongda Hospital Affiliated to Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU

Description

Inclusion Criteria:

• Shock patients admitted to the ICU are defined as those with persistent hypotension (systolic blood pressure < 90 mmHg or a decrease of ≥ 40 mmHg from the baseline blood pressure) accompanied by signs of tissue hypoperfusion.
• Age ≥ 18 years old.
• The patient or their legal representatives signed the informed consent form.

Exclusion Criteria:

• Patients with severe pulmonary circulatory disorders such as severe pulmonary hypertension and acute pulmonary embolism.
• Patients with right ventricular myocardial infarction or severe tricuspid regurgitation.
• Patients with severe neck trauma or deformity that affects Doppler examination of cervical arteries and veins, or those with anatomical contraindications preventing evaluation of at least one cervical artery or vein.
• Pregnant or lactating women.
• Patients with diseases that may interfere with abdominal ultrasound examination.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hands-free Carotid Artery and Vein Doppler Parameters	Elevate the patient's upper body to 45°, keep the legs flat, place the long axis of the probe perpendicular to the carotid vessels (with the probe height not exceeding the upper edge of the thyroid cartilage), locate the optimal signals of the common carotid artery and internal jugular vein waveforms, and then fix the probe.	Time of shock in ICU within 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PiCCO	Inject cold saline through central venous catheterization, sense temperature changes via arterial catheter, and obtain hemodynamic parameters such as cardiac output by combining thermodilution and pulse contour analysis.	Time of shock in ICU within 3 days
Venous Excess Ultrasound Score	Evaluate the diameter, waveform, etc. of the inferior vena cava, hepatic veins, portal vein, and intrarenal veins sequentially via ultrasound, and comprehensively derive a grade ranging from 0 to 3.Grade 0: No congestion; Grade 1: Mild congestion; Grade 2: Moderate congestion; Grade 3: Severe congestion.	Time of shock in ICU within 3 days
Bioelectrical Impedance Analysis	Attach electrodes to the patient's limbs, input basic information, measure impedance of multiple parts with multi-frequency technology, and quickly obtain parameters such as body composition.	Time of shock in ICU within 3 days
Duration of shock	Time of shock in ICU within 28 days	Time of shock in ICU within 28 days
Duration of Mechanical Ventilation	Duration of Mechanical Ventilation During ICU Admission	up to 24 weeks
Total Length of Hospital Stay	Total Length of Hospital Stay	up to 24 weeks
Length of ICU stay	Length of ICU stay	up to 24 weeks
mortality of 28 days	Incidence of death during 28 days	Incidence of death during 28 days
In-hospital Mortality	In-hospital Mortality	up to 24 weeks
Vasoactive Agent Dosage	Vasoactive Agent Dosage During ICU Admission	up to 24 weeks
Time without vasoactive agents within 28 days	Time without vasoactive agents within 28 days	Time without vasoactive agents within 28 days

Collaborators and Investigators

• Sponsor: Southeast University, China

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Shock; Fluid Overload; Fluid Responsiveness; Fluid Resuscitation; VExUS
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shock; Edema
• Other Study ID Numbers: 20251107 fluid management

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No