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NCT Number: NCT07373717

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

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.

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Key information

Conditions

Shock Edema Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hands-free Carotid Artery and Vein Doppler Parameters

    Time frame: Time of shock in ICU within 3 days

    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.

Secondary outcomes

  1. PiCCO

    Time frame: Time of shock in ICU within 3 days

    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.

  2. Venous Excess Ultrasound Score

    Time frame: Time of shock in ICU within 3 days

    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.

  3. Bioelectrical Impedance Analysis

    Time frame: Time of shock in ICU within 3 days

    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.

  4. Duration of shock

    Time frame: Time of shock in ICU within 28 days

    Time of shock in ICU within 28 days

  5. Duration of Mechanical Ventilation

    Time frame: up to 24 weeks

    Duration of Mechanical Ventilation During ICU Admission

  6. Total Length of Hospital Stay

    Time frame: up to 24 weeks

    Total Length of Hospital Stay

  7. Length of ICU stay

    Time frame: up to 24 weeks

    Length of ICU stay

  8. mortality of 28 days

    Time frame: Incidence of death during 28 days

    Incidence of death during 28 days

  9. In-hospital Mortality

    Time frame: up to 24 weeks

    In-hospital Mortality

  10. Vasoactive Agent Dosage

    Time frame: up to 24 weeks

    Vasoactive Agent Dosage During ICU Admission

  11. Time without vasoactive agents within 28 days

    Time frame: Time without vasoactive agents within 28 days

    Time without vasoactive agents within 28 days

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

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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