Central Venous Pressure Versus Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients

November 30, 2025 updated by: Marwa Abdelmomen Helal, Assiut University

Comparison of Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients

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

Study Overview

Detailed Description

Sepsis and septic shock remain among the leading causes of morbidity and mortality in intensive care units worldwide. Septic shock is defined as a subset of sepsis characterized by profound circulatory, cellular, and metabolic dysfunction, associated with a high risk of death despite adequate fluid resuscitation, vasopressor support, and infection source control. The cornerstone of early septic shock management is hemodynamic resuscitation, with intravenous fluids serving as the first-line therapy to restore effective circulating blood volume, improve cardiac output, and optimize tissue perfusion. However, while adequate fluid administration is lifesaving, excessive fluid loading can be detrimental, leading to interstitial edema, impaired oxygen delivery, increased intra-abdominal pressure, and pulmonary edema that may worsen outcomes. Therefore, precise identification of patients who are "fluid responsive" is of paramount clinical importance.

A direct comparison between CVP (as a traditional, static marker) and IVC distensibility index (as a dynamic marker) in patients with septic shock is essential to determine their relative value in guiding fluid resuscitation. This study aims to evaluate and compare the predictive accuracy, feasibility, and clinical applicability of these two parameters as tools for identifying fluid responsiveness in septic shock patients. The results may provide valuable insight into optimizing fluid resuscitation strategies, minimizing fluid overload, and ultimately improving patient outcomes.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult patients aged (≥18 years old) yearpresenting with septic shock to the emergency department and requiring volume status assessment through both IVC ultrasound and central venous pressure monitoring

Description

  1. Inclusion criteria:

    • Adult patients (≥18 years old) both gender. with a clinical diagnosis of septic shock according to Sepsis-3 criteria (persistent hypotension require vasopressors to maintain MAP ≥65 mmHg and serum lactate >2 mmol/L despite adequate fluid resuscitation).(2,3).
    • with a central venous catheter in place for CVP monitoring. .awho require fluid resuscitation.
  2. Exclusion criteria:

.pregnant patients. .Patients with significant right heart failure or severe tricuspid regurgitation (5)..

.Patients with increased intra-abdominal pressure or conditions affecting IVC diameter (9).

.Patients with arrhythmias (e.g., atrial fibrillation) that interfere with preload assessment (6).

.Patients who refuse participation.

  • patients with contraindications to cvp (coagulopathy,distortion in anatomy of neck,....)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the accuracy of Central Venous Pressure (CVP) and Inferior Vena Cava Distensibility Index (IVC-DI) in predicting fluid responsiveness in patients with septic shock.
Time Frame: All patients will have the measurements of CVP and IVC_DI on arrival within 30 min before resuscitation and after 60 min of resuscitation
All patients will have the measurements of CVP and IVC_DI on arrival within 30 min before resuscitation and after 60 min of resuscitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CVP-IVCDI-IN SEPTIC SHOCK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ultrasound guided inferior vena cava distensibility index

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