ShockNCT07206732
IVC Ultrasound Versus Central Venous Pressure for Early Detection of Hypovolemia in Shock Patients
An observational study of Shock and Hypovolemia, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shock, Hypovolemia, Circulatory Failure
- What is being tested?
- Ultrasound-Guided Inferior Vena Cava Assessment
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 15 Dec 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1- 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.
Who cannot join
- 1 - Patients younger than 18 years. 2. Pregnancy. 3.Cardiogenic or obstructive shock (e.g., cardiac tamponade, massive pulmonary embolism, or tension pneumothorax).
- 4.Known inferior vena cava (IVC) anomalies (e.g., congenital absence, thrombosis).
- 5. Increased intra-abdominal pressure or severe ascites. 6. Morbid obesity (BMI ≥40 kg/m²) or any condition interfering with adequate IVC ultrasound visualization.
- 7. Prior central venous catheterization performed before Emergency Department arrival.
- 8. Congestive heart failure (CHF) with left ventricular ejection fraction (LVEF <40%) or pulmonary hypertension.
- 9. Refusal of the patient or legal guardian to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Emeregency medicine department ,Assiut University
Asyut, Sahel Selim
Mahmoud Ahmed Mohamed Abd Elgwad, M.B.B.Ch, +01280752523, mahmoudataay12@gmail.com
About this study
Official title: Ultrasound-Guided Inferior Vena Cava Assessment Versus Central Venous Pressure Monitoring in Early and Post-Resuscitation Detection of Hypovolemia Among Shocked Patients in the Emergency Department
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.
Read the detailed description
Hypovolemia is a major contributor to morbidity and mortality among patients presenting with shock in the emergency department. Early recognition and accurate assessment of intravascular volume status are essential for effective resuscitation. Central venous pressure (CVP) monitoring has traditionally been used but is invasive and may not always accurately reflect volume status. Ultrasound-guided inferior vena cava (IVC) assessment offers a non-invasive alternative, with the IVC collapsibility index shown to correlate with volume responsiveness. This prospective observational study will enroll patients diagnosed with shock and compare IVC measurements with CVP values during both early presentation and post-resuscitation phases. The findings are expected to provide evidence on the diagnostic agreement between IVC ultrasound and CVP monitoring, potentially supporting the use of IVC ultrasound as a rapid, reliable, and less invasive tool for guiding fluid therapy in emergency settings.
- Conditions
- Shock, Hypovolemia, Circulatory Failure
- Being tested
- Ultrasound-Guided Inferior Vena Cava Assessment
- Keywords
- Shock, Hypovolemia, Emergency department, Central venous pressure, Fliud resuscitation, Ultrasound guided IVC
- Medical subject headings
- Shock, Hypovolemia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Inferior Vena Cava AssessmentDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mohamed Abd Elgwad, Assiut University
- Investigators
- Alaa M Attia, Professor of Anathesia and ICU, Principal investigator, Assit UniversityAhmed M Mandor, Consultant of Anathesia ICU, Study director, Assiut UniversityWalaa M Adel, Lecture of emergency medicine, Study director, Seuz canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206732
- Sponsor's protocol ID
- IVC-CVP-ShockED-2025
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Inferior Vena Cava Assessment Versus Central Venous Pressure Monitoring in Early and Post-Resuscitation Detection of Hypovolemia Among Shocked Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT07206732
- Acronym / sponsor ID
- IVC-CVP-ShockED-2025
- Conditions
- Shock, Hypovolemia, Circulatory Failure
- Keywords
- Shock, Hypovolemia, Emergency department, Central venous pressure, Fliud resuscitation, Ultrasound guided IVC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (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 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.
Detailed description
Hypovolemia is a major contributor to morbidity and mortality among patients presenting with shock in the emergency department. Early recognition and accurate assessment of intravascular volume status are essential for effective resuscitation. Central venous pressure (CVP) monitoring has traditionally been used but is invasive and may not always accurately reflect volume status. Ultrasound-guided inferior vena cava (IVC) assessment offers a non-invasive alternative, with the IVC collapsibility index shown to correlate with volume responsiveness. This prospective observational study will enroll patients diagnosed with shock and compare IVC measurements with CVP values during both early presentation and post-resuscitation phases. The findings are expected to provide evidence on the diagnostic agreement between IVC ultrasound and CVP monitoring, potentially supporting the use of IVC ultrasound as a rapid, reliable, and less invasive tool for guiding fluid therapy in emergency settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 1- 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.
Key exclusion criteria (6 listed)
- 1 - Patients younger than 18 years. 2. Pregnancy. 3.Cardiogenic or obstructive shock (e.g., cardiac tamponade, massive pulmonary embolism, or tension pneumothorax).
- 4.Known inferior vena cava (IVC) anomalies (e.g., congenital absence, thrombosis).
- 5. Increased intra-abdominal pressure or severe ascites. 6. Morbid obesity (BMI ≥40 kg/m²) or any condition interfering with adequate IVC ultrasound visualization.
- 7. Prior central venous catheterization performed before Emergency Department arrival.
- 8. Congestive heart failure (CHF) with left ventricular ejection fraction (LVEF <40%) or pulmonary hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Inferior Vena Cava AssessmentThis 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. | Device | – |
Primary outcome
Correlation Between IVC Collapsibility Index and Central Venous Pressure
Time frame: 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.
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
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 19 Nov 2025.
- Individual participant dataSharing planned: No. 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.
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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.
Alaa M Attia, Professor of Anathesia and ICU principal investigator
Assit University
Ahmed M Mandor, Consultant of Anathesia ICU study director
Assiut University
Walaa M Adel, Lecture of emergency medicine study director
Seuz canal University
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 and Hypovolemia, run by Assiut University at 1 site in Egypt.
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 6 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: opening soon, as of the sponsor's last update on 19 Nov 2025. 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 Egypt. 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?
Contact Mahmoud Ahmed Mohamed Abd Elgwad, M.B.B.Ch (+01280752523, mahmoudataay12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between IVC Collapsibility Index and Central Venous Pressure (time frame: 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.). 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 19 Nov 2025.