Fluid OverloadVExUS ICUNCT06585722
Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU Population
An observational study of Fluid Overload and Kidney Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Kidney Injury, Make-30
- How many people
- 136 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2023to 5 Sep 2024
- 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: All cricitally ill patients who are expected to be admitted to the ICU for more than 24 hours and who do not meet the exclusion criteria
Who may be able to join
- all patients admitted to the ICU 18 years or older expected to stay in the ICU for more than 24 hours
Who cannot join
- any obstruction between the righ atrium and structures assessed by VExUS
- a medical history of: Major cardiac shunts (e.g. atrial septum defect), Tricuspid regurgitation, dialysis, portal hypertension, pulmonary hypertension, interstitial lung disease, recipients of a kidney of liver transplant.
- patients in whom an ultrasound assesment is unfeasible e.g. a BMI over 40
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081HV
P R tuinman, PhD, 020 444 4444, p.tuinman@amsterdamumc.nl
About this study
Official title: The Association Between Venous Excess Ultrasound, the Lung Ultrasound Score and Acute Kidney Injury and Death in the Intensive Care Unit Population
Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.
Read the detailed description
This study will investigate the association between the venous excess ultrasound grading system (VExUS) and patient relevant outcomes such as acute kidney injury, mortality and length of stay.
A secondary analysis is planned where the association between VExUS and the lung ultrasound score will be investigated
- Conditions
- Fluid Overload, Kidney Injury, Make-30
- Medical subject headings
- Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute kidney injury
Clinically relevant acute kidney injury in the ICU: a 200% rise in creatinine or the use of renal replacement therapy
Measured: within 30 days of admission to the ICU
Mortality
death of all causes
Measured: within 30 days of admission to the ICU
Rate of MAKE-30
a composite endpoint of mortality and acute kidney injury ( including renal replacement therapy)
Measured: within 30 days of admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Feb 2023
- Primary completion5 Sep 2024 (estimated)
- Study completion5 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P.R. Tuinman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585722
- Sponsor's protocol ID
- 2020.01111
- Acronym
- VExUS ICU
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Venous Excess Ultrasound, the Lung Ultrasound Score and Acute Kidney Injury and Death in the Intensive Care Unit Population
- ClinicalTrials.gov ID
- NCT06585722
- Acronym / sponsor ID
- VExUS ICU / 2020.01111
- Conditions
- Fluid Overload, Kidney Injury, Make-30
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 5 Sep 2024 (estimated)
- Study completion
- 5 Sep 2024 (estimated)
- First posted
- 5 Sep 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.
Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.
Detailed description
This study will investigate the association between the venous excess ultrasound grading system (VExUS) and patient relevant outcomes such as acute kidney injury, mortality and length of stay.
A secondary analysis is planned where the association between VExUS and the lung ultrasound score will be investigated
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cricitally ill patients who are expected to be admitted to the ICU for more than 24 hours and who do not meet the exclusion criteria
Key inclusion criteria (1 listed)
- all patients admitted to the ICU 18 years or older expected to stay in the ICU for more than 24 hours
Key exclusion criteria (3 listed)
- any obstruction between the righ atrium and structures assessed by VExUS
- a medical history of: Major cardiac shunts (e.g. atrial septum defect), Tricuspid regurgitation, dialysis, portal hypertension, pulmonary hypertension, interstitial lung disease, recipients of a kidney of liver transplant.
- patients in whom an ultrasound assesment is unfeasible e.g. a BMI over 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of acute kidney injury
Time frame: within 30 days of admission to the ICU
Clinically relevant acute kidney injury in the ICU: a 200% rise in creatinine or the use of renal replacement therapy
Mortality
Time frame: within 30 days of admission to the ICU
death of all causes
Rate of MAKE-30
Time frame: within 30 days of admission to the ICU
a composite endpoint of mortality and acute kidney injury ( including renal replacement therapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Capital Offload-Shock
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Dry Weight Reduction Intervention Via Extra Ultrafiltration
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Not yet recruiting
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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.
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 Fluid Overload and Kidney Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter R Tuinman, PhD (0204444444, p.tuinman@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute kidney injury (time frame: within 30 days of admission to the ICU). The study lists 3 primary outcomes in all. 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 5 Sep 2024.