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Enrolling by invitation NCT07373717

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

Observational Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Hands-free Carotid Artery and Vein Doppler Parameters [Time frame: Time of shock in ICU within 3 days]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Zhongda Hospital Affiliated to Southeast University — Nanjing

Identifiers

NCT: NCT07373717 · 20251107 fluid management

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗