Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked PatientsNCT07279064
Central Venous Pressure Versus Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients
An observational study of Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients
- What is being tested?
- Ultrasound guided inferior vena cava distensibility index
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Oct 2027
- 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 years and older
- All sexes
- Adult, Older adult
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
- 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.
- 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,....)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Being tested
- Ultrasound guided inferior vena cava distensibility index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided inferior vena cava distensibility indexDevice
This intervention involves bedside ultrasound measurement of the inferior vena cava (IVC) diameter and calculation of the IVC 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All patients will have the measurements of CVP and IVC_DI on arrival within 30 min before resuscitation and after 60 min of resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked PatientsStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelmomen Helal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279064
- Sponsor's protocol ID
- CVP-IVCDI-IN SEPTIC SHOCK
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients
- ClinicalTrials.gov ID
- NCT07279064
- Acronym / sponsor ID
- CVP-IVCDI-IN SEPTIC SHOCK
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Dec 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 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
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 distensibility indexThis intervention involves bedside ultrasound measurement of the inferior vena cava (IVC) diameter and calculation of the IVC 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. | Device | – |
Primary outcome
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
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 12 Dec 2025.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Marwa Abdelmomen Helal (01008118263, marwaamomen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 12 Dec 2025.