Volume StatusHOCUS-POCUSNCT06379347
HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound
An observational study of Volume Status, run by Flevoziekenhuis at 1 site in Netherlands.
Trial summary
Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Volume Status
- What is being tested?
- POCUS performed on clinical indication
- How many people
- 98 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the general ward with a clinical indication for performing VCI ultrasound.
Who may be able to join
- Patient is over 18 years old.
- Patient has a clinical indication for making a IVC ultrasound.
- Patient is admitted until at least 24 hours after the first ultrasound.
Who cannot join
- Patients who are using vasopressors at the time of the ultrasound.
- Patients who require invasive or non-invasive (optiflow, CPAP, BPAP) ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward.
Read the detailed description
The study will be carried out on patients over the age of 18 who were admitted to the general ward between for at least 24 hours and who had a clinical indication for an IVC ultrasound. Patients are informed through an informed consent form and are given the opportunity to opt-out. When there are no objections, the patient's data is collected for the study. Patients who are using vasopressors at the time of the ultrasound are excluded from the study. In addition, patients who require invasive or non-invasive ventilation (optiflow, CPAP, BPAP) are also excluded.
The ultrasounds are performed by trained physicians based on a standard operating procedure. The longitudinal portion of the IVC is scanned and a cine loop of 10 seconds is made during a respiratory cycle to determine the diameter of the IVC (dIVC). After the recording is paused, the dIVC will be measured 2 cm caudal to the junction of the hepatic vein and IVC to standardize the measurements. Measurements are taken at peak expiration (dIVCe) and inspiration (dIVCi) by measuring the vein lumen at one respiratory cycle from one interior wall to the opposite interior wall.
Data is collected at the time of admission and after 48 hours (or prematurely if the patient is discharged). During the initial assessment, the patient's demographics, clinical data, physical examination, vitals , laboratory parameters, and the POCUS IVC (minimal and maximal diameter, percentage collapse) are registered. The Charlson Comorbidity Index is used to quantify the severity of comorbidities in the patients. Additionally, the patient's overall health status is measured by the ECOG Performance Status Scale.
Once the initial measurements are done, a clinical diagnosis of the patient's volume status will be established. 48 hours later, more data will be gathered for the follow-up. The data includes vitals and laboratory parameters. It is also noted whether the POCUS influenced the management of treatment (IV fluid or diuretic therapy) of each patient. Following this assessment, a clinical diagnosis in retrospect at the time of the ultrasound at baseline about the volume status is established.
The diagnostic accuracy for hypovolemia and hypervolemia cases are analyzed. The sensitivity, specificity, positive predictive value, and negative predictive value are also determined. Furthermore, the area under the curve (AUC) for hypo- and hypervolemia were computed.
A descriptive analysis of the changes over time will be carried out in the subgroup with follow-up measurements. The interpretation of the images at the time of the ultrasound serves as the foundation for the main analysis. A second assessor will verify the images retrospectively in a subset, recalculating the diameter and evaluating their quality. A descriptive analysis will be conducted on the quality of measurements. Moreover, an exploratory analysis will be carried out to ascertain the best location and cutoff points for identifying volume status.
- Conditions
- Volume Status
- Being tested
- POCUS performed on clinical indication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUS performed on clinical indicationDiagnostic test
POCUS performed on clinical indication
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume status
Depleted, overloaded, or normal volume status at baseline, determined 48 hours after performing the ultrasound.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start28 Feb 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Volume StatusStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flevoziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen de Heer, MD PhD, Principal investigator, Flevoziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379347
- Sponsor's protocol ID
- FZ 23/41
- Acronym
- HOCUS-POCUS
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.
PubMed 2386120
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound
- ClinicalTrials.gov ID
- NCT06379347
- Acronym / sponsor ID
- HOCUS-POCUS / FZ 23/41
- Conditions
- Volume Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- FlevoziekenhuisUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 23 Apr 2024 (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.
Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward.
Detailed description
The study will be carried out on patients over the age of 18 who were admitted to the general ward between for at least 24 hours and who had a clinical indication for an IVC ultrasound. Patients are informed through an informed consent form and are given the opportunity to opt-out. When there are no objections, the patient's data is collected for the study. Patients who are using vasopressors at the time of the ultrasound are excluded from the study. In addition, patients who require invasive or non-invasive ventilation (optiflow, CPAP, BPAP) are also excluded.
The ultrasounds are performed by trained physicians based on a standard operating procedure. The longitudinal portion of the IVC is scanned and a cine loop of 10 seconds is made during a respiratory cycle to determine the diameter of the IVC (dIVC). After the recording is paused, the dIVC will be measured 2 cm caudal to the junction of the hepatic vein and IVC to standardize the measurements. Measurements are taken at peak expiration (dIVCe) and inspiration (dIVCi) by measuring the vein lumen at one respiratory cycle from one interior wall to the opposite interior wall.
Data is collected at the time of admission and after 48 hours (or prematurely if the patient is discharged). During the initial assessment, the patient's demographics, clinical data, physical examination, vitals , laboratory parameters, and the POCUS IVC (minimal and maximal diameter, percentage collapse) are registered. The Charlson Comorbidity Index is used to quantify the severity of comorbidities in the patients. Additionally, the patient's overall health status is measured by the ECOG Performance Status Scale.
Once the initial measurements are done, a clinical diagnosis of the patient's volume status will be established. 48 hours later, more data will be gathered for the follow-up. The data includes vitals and laboratory parameters. It is also noted whether the POCUS influenced the management of treatment (IV fluid or diuretic therapy) of each patient. Following this assessment, a clinical diagnosis in retrospect at the time of the ultrasound at baseline about the volume status is established.
The diagnostic accuracy for hypovolemia and hypervolemia cases are analyzed. The sensitivity, specificity, positive predictive value, and negative predictive value are also determined. Furthermore, the area under the curve (AUC) for hypo- and hypervolemia were computed.
A descriptive analysis of the changes over time will be carried out in the subgroup with follow-up measurements. The interpretation of the images at the time of the ultrasound serves as the foundation for the main analysis. A second assessor will verify the images retrospectively in a subset, recalculating the diameter and evaluating their quality. A descriptive analysis will be conducted on the quality of measurements. Moreover, an exploratory analysis will be carried out to ascertain the best location and cutoff points for identifying volume status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the general ward with a clinical indication for performing VCI ultrasound.
Key inclusion criteria (3 listed)
- Patient is over 18 years old.
- Patient has a clinical indication for making a IVC ultrasound.
- Patient is admitted until at least 24 hours after the first ultrasound.
Key exclusion criteria (2 listed)
- Patients who are using vasopressors at the time of the ultrasound.
- Patients who require invasive or non-invasive (optiflow, CPAP, BPAP) ventilation.
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 |
|---|---|---|
| POCUS performed on clinical indicationPOCUS performed on clinical indication | Diagnostic test | – |
Primary outcome
Volume status
Time frame: 48 hours
Depleted, overloaded, or normal volume status at baseline, determined 48 hours after performing the ultrasound.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 2386120Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.
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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. This study is not recruiting at the moment.
Koen de Heer, MD PhD principal investigator
Flevoziekenhuis
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 Volume Status, run by Flevoziekenhuis at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 30 Oct 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume status (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379347, which also lists 1 linked publication.
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 30 Oct 2026.