NCT07373717

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Nov 2025Mar 2027

Study Start

First participant enrolled

November 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

December 29, 2025

Last Update Submit

January 23, 2026

Conditions

Keywords

VExUSFluid ResuscitationFluid ResponsivenessFluid OverloadShock

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • PiCCO

    Time of shock in ICU within 3 days

  • Venous Excess Ultrasound Score

    Time of shock in ICU within 3 days

  • Bioelectrical Impedance Analysis

    Time of shock in ICU within 3 days

  • Duration of shock

    Time of shock in ICU within 28 days

  • Duration of Mechanical Ventilation

    up to 24 weeks

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ICU

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

ShockEdema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 28, 2026

Study Start

November 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations