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

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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