ShockNCT07373717
Consistency of Fluid Tolerance Evaluation Methods and Their Correlation With Clinical Outcomes in Patients With Shock
An observational study of Shock, run by Southeast University, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, 210000
About this study
Official title: 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.
- Conditions
- Shock
- Keywords
- VExUS, Fluid Resuscitation, Fluid Responsiveness, Fluid Overload, Shock
- Medical subject headings
- Shock, Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time of shock in ICU within 3 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: Time of shock in ICU within 3 days
Duration of shock
Time of shock in ICU within 28 days
Measured: Time of shock in ICU within 28 days
Duration of Mechanical Ventilation
Duration of Mechanical Ventilation During ICU Admission
Measured: up to 24 weeks
Total Length of Hospital Stay
Total Length of Hospital Stay
Measured: up to 24 weeks
Length of ICU stay
Length of ICU stay
Measured: up to 24 weeks
mortality of 28 days
Incidence of death during 28 days
Measured: Incidence of death during 28 days
In-hospital Mortality
In-hospital Mortality
Measured: up to 24 weeks
Vasoactive Agent Dosage
Vasoactive Agent Dosage During ICU Admission
Measured: up to 24 weeks
Time without vasoactive agents within 28 days
Time without vasoactive agents within 28 days
Measured: Time without vasoactive agents within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start2 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373717
- Sponsor's protocol ID
- 20251107 fluid management
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency of Fluid Tolerance Evaluation Methods and Their Correlation With Clinical Outcomes in Shock Patients:A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07373717
- Acronym / sponsor ID
- 20251107 fluid management
- Conditions
- Shock
- Keywords
- VExUS, Fluid Resuscitation, Fluid Responsiveness, Fluid Overload, Shock
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
PiCCO
Time frame: Time of shock in ICU within 3 days
Venous Excess Ultrasound Score
Time frame: Time of shock in ICU within 3 days
Bioelectrical Impedance Analysis
Time frame: Time of shock in ICU within 3 days
Duration of shock
Time frame: Time of shock in ICU within 28 days
Duration of Mechanical Ventilation
Time frame: up to 24 weeks
Total Length of Hospital Stay
Time frame: up to 24 weeks
Length of ICU stay
Time frame: up to 24 weeks
mortality of 28 days
Time frame: Incidence of death during 28 days
In-hospital Mortality
Time frame: up to 24 weeks
Vasoactive Agent Dosage
Time frame: up to 24 weeks
Time without vasoactive agents within 28 days
Time frame: Time without vasoactive agents within 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hands-free Carotid Artery and Vein Doppler Parameters (time frame: Time of shock in ICU within 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.