NCT07206732

Brief Summary

This study aims to compare ultrasound-guided inferior vena cava (IVC) assessment with central venous pressure (CVP) monitoring for the detection of hypovolemia in shock patients in the emergency department. The primary objective is to evaluate the diagnostic accuracy and clinical utility of IVC collapsibility index compared to CVP values in both early and post-resuscitation phases. The study will prospectively enroll shock patients, collect demographic and clinical data, and analyze the correlation between IVC and CVP measurements to determine their role in guiding fluid resuscitation and hemodynamic management.

Trial Health

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Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

November 19, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 26, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

ShockHypovolemiaEmergency departmentCentral venous pressureFliud resuscitationUltrasound guided IVC

Outcome Measures

Primary Outcomes (1)

  • Correlation Between IVC Collapsibility Index and Central Venous Pressure

    The primary outcome is to assess the diagnostic agreement between ultrasound-guided inferior vena cava (IVC) collapsibility index and central venous pressure (CVP) values in detecting hypovolemia among shock patients in the emergency department. Measurements will be collected at two time points: during early presentation and after initial fluid resuscitation. The outcome will be evaluated by analyzing correlation coefficients, sensitivity, and specificity of IVC measurements compared with CVP

    IVC assessment will be performed at presentation and 1 hour post-resuscitation, while CVP will be monitored continuously during the first 6 hours after ED admission.

Interventions

This intervention involves bedside ultrasound measurement of the inferior vena cava (IVC) diameter and calculation of the IVC collapsibility/distensibility index. Assessments will be performed both at initial presentation and after fluid resuscitation in shock patients. The procedure is non-invasive, rapid, and performed according to standardized emergency ultrasound protocols, distinguishing it from invasive monitoring methods.

Eligibility Criteria

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

The study population will include adult patients aged 18-65 years presenting with shock to the emergency department and requiring volume status assessment through both IVC ultrasound and central venous pressure monitoring.

You may qualify if:

  • Adult patients aged ≥18 years. 2.Both male and female patients will be included in the study. 3. Presentation to the Emergency Department with clinical evidence of shock, defined by: Hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg).
  • Evidence of tissue hypoperfusion (e.g., altered mental status, cold extremities, or oliguria).
  • Elevated serum lactate (\>2 mmol/L). 4. Shock attributed to hypovolemic, septic, or hemorrhagic etiologies. 5. Patients requiring fluid resuscitation and hemodynamic monitoring.

You may not qualify if:

  • Patients younger than 18 years. 2. Pregnancy. 3.Cardiogenic or obstructive shock (e.g., cardiac tamponade, massive pulmonary embolism, or tension pneumothorax).
  • Known inferior vena cava (IVC) anomalies (e.g., congenital absence, thrombosis).
  • \. Increased intra-abdominal pressure or severe ascites. 6. Morbid obesity (BMI ≥40 kg/m²) or any condition interfering with adequate IVC ultrasound visualization.
  • \. Prior central venous catheterization performed before Emergency Department arrival.
  • \. Congestive heart failure (CHF) with left ventricular ejection fraction (LVEF \<40%) or pulmonary hypertension.
  • \. Refusal of the patient or legal guardian to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emeregency medicine department ,Assiut University

Asyut, Sahel Selim, Egypt

Location

MeSH Terms

Conditions

ShockHypovolemiaEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Alaa M Attia, Professor of Anathesia and ICU

    Assit University

    PRINCIPAL INVESTIGATOR
  • Ahmed M Mandor, Consultant of Anathesia ICU

    Assiut University

    STUDY DIRECTOR
  • Walaa M Adel, Lecture of emergency medicine

    Seuz canal University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Ahmed Mohamed Abd Elgwad, M.B.B.Ch

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator at Emergency Medicine department Assiut University

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

November 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study is conducted as part of an academic thesis project. Data are limited to internal use within the research team and protected by institutional and ethical regulations.

Locations