Acute Kidney InjuryNCT06889116
VExUS Score and AKI in Critically Ill Adult patients-a Prospective Observational Study.
An observational study of Acute Kidney Injury and VExUS, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
Introduction Renal perfusion is dependent on the renal perfusion pressure across the renal capillaries. Venous congestion due to excess fluid therapy can drastically reduce the renal perfusion pressure in spite of a normal mean arterial pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, VExUS
- How many people
- 52 participants
- Where
- 1 siteNepal
- Study dates
- 15 May 2023to 11 Jan 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: Patients who had AKI at the time of admission or who developed AKI during their ICU stay were screened for inclusion.
Who may be able to join
- Age ≥18 years
- Admitted to the adult ICUs of TUTH (ICU A and ICU B)
- Admitting diagnosis of AKI or who developed AKI during their ICU stay
Who cannot join
- Pregnancy
- Diagnosed case of chronic kidney disease
- Diagnosed case of cirrhosis/ portal hypertension
- Arrhythmias which would interfere with the acquisition and interpretation of the Doppler waveforms
- Inferior venacava thrombus
- Poor window for assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Point of Care Venous Excess Ultrasonography (VExUS) Score and Acute Kidney Injury (AKI) in Critically Ill Adult Patients- a Prospective Observational Study.
Introduction Renal perfusion is dependent on the renal perfusion pressure across the renal capillaries. Venous congestion due to excess fluid therapy can drastically reduce the renal perfusion pressure in spite of a normal mean arterial pressure. Increasing cumulative fluid balance during the ICU stay has been found to be associated with negative outcomes including acute kidney injury (AKI) and hospital mortality. Venous excess ultrasound (VExUS) to assess the Doppler studies of renal, hepatic and portal veins along with the inferior venacava has been shown to reliably predict the incidence of AKI in certain ICU patient population more specifically in cardiorenal syndrome. The aim of this study was to correlate the incidence of AKI and VExUS scores in a mixed ICU population and hence determine the contribution of venous congestion on the causation of AKI in a general ICU.
Methods:
The patients included who have AKI at admission or developed AKI during their ICU stay were included. The definition of AKI used for this study was as defined by Kidney Disease: Improving Global Outcomes (KDIGO). Point of care VExUS scans were done on each patient at inclusion (day 0), then each day for a total of 4 days (day 1, 2 and 3), till initiation of renal replacement therapy, death or discharge form the ICU. Correlation between VExUS grades and creatinine clearances was explored as the primary objective.
- Conditions
- Acute Kidney Injury, VExUS
- Keywords
- VExUS, Acute Kidney Injury, Cumulative fluid balance, Point of Care Ultrasound
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AKI | Patients who are admitted with the diagnosis of AKI or develop AKI during their ICU stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine correlation between the VExUS score with creatinine clearance.
Measured: At the end of Day 3 or initiation of renal replacement therapy or resolution of AKI, death or discharge from the ICU. whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start15 May 2023
- Primary completion7 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bipin Karki, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889116
- Sponsor's protocol ID
- 438(6-11)E2- 079/080
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Point of Care Venous Excess Ultrasonography (VExUS) Score and Acute Kidney Injury (AKI) in Critically Ill Adult Patients- a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06889116
- Acronym / sponsor ID
- 438(6-11)E2- 079/080
- Conditions
- Acute Kidney Injury, VExUS
- Keywords
- VExUS, Acute Kidney Injury, Cumulative fluid balance, Point of Care Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 21 Mar 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.
Introduction Renal perfusion is dependent on the renal perfusion pressure across the renal capillaries. Venous congestion due to excess fluid therapy can drastically reduce the renal perfusion pressure in spite of a normal mean arterial pressure. Increasing cumulative fluid balance during the ICU stay has been found to be associated with negative outcomes including acute kidney injury (AKI) and hospital mortality. Venous excess ultrasound (VExUS) to assess the Doppler studies of renal, hepatic and portal veins along with the inferior venacava has been shown to reliably predict the incidence of AKI in certain ICU patient population more specifically in cardiorenal syndrome. The aim of this study was to correlate the incidence of AKI and VExUS scores in a mixed ICU population and hence determine the contribution of venous congestion on the causation of AKI in a general ICU.
Methods:
The patients included who have AKI at admission or developed AKI during their ICU stay were included. The definition of AKI used for this study was as defined by Kidney Disease: Improving Global Outcomes (KDIGO). Point of care VExUS scans were done on each patient at inclusion (day 0), then each day for a total of 4 days (day 1, 2 and 3), till initiation of renal replacement therapy, death or discharge form the ICU. Correlation between VExUS grades and creatinine clearances was explored as the primary objective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with AKI | – | –Patients who are admitted with the diagnosis of AKI or develop AKI during their ICU stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had AKI at the time of admission or who developed AKI during their ICU stay were screened for inclusion.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Admitted to the adult ICUs of TUTH (ICU A and ICU B)
- Admitting diagnosis of AKI or who developed AKI during their ICU stay
Key exclusion criteria (6 listed)
- Pregnancy
- Diagnosed case of chronic kidney disease
- Diagnosed case of cirrhosis/ portal hypertension
- Arrhythmias which would interfere with the acquisition and interpretation of the Doppler waveforms
- Inferior venacava thrombus
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
To determine correlation between the VExUS score with creatinine clearance.
Time frame: At the end of Day 3 or initiation of renal replacement therapy or resolution of AKI, death or discharge from the ICU. whichever came first.
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 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Kidney Injury and VExUS, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 6 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 21 Mar 2025. 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 Nepal. 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?
To determine correlation between the VExUS score with creatinine clearance. (time frame: At the end of Day 3 or initiation of renal replacement therapy or resolution of AKI, death or discharge from the ICU. whichever came first.). 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 21 Mar 2025.