IVC Ultrasound Versus Central Venous Pressure for Early Detection of Hypovolemia in Shock Patients

NCT ID: NCT07206732

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-12-15

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound-Guided Inferior Vena Cava Assessment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Ahmed Mohamed Abd Elgwad

Principal Investigator at Emergency Medicine department Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa M Attia, Professor of Anathesia and ICU

Role: PRINCIPAL_INVESTIGATOR

Assit University

Ahmed M Mandor, Consultant of Anathesia ICU

Role: STUDY_DIRECTOR

Assiut University

Walaa M Adel, Lecture of emergency medicine

Role: STUDY_DIRECTOR

Seuz canal University

Locations

Emeregency medicine department ,Assiut University

Asyut, Sahel Selim, Egypt

Countries

Egypt

Central Contacts

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

Role: CONTACT

mahmoudataay12@gmail.com

+01280752523

Facility Contacts

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

Role: primary

mahmoudataay12@gmail.com

+01280752523

Other Identifiers

IVC-CVP-ShockED-2025

Identifier Type: -

Identifier Source: org_study_id