Acute Kidney Failure Stage 3VExLUS-KRTNCT06254703
Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients
An observational study of Acute Kidney Failure Stage 3, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Hemodynamic management of critically ill patients has long been focused on the arterial side of the vasculature by assessing adequate perfusion pressure. However, the venous pressure is also of critical importance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure Stage 3
- What is being tested?
- VExUS (venous excess ultrasound) and modified VExUS (modified venous excess ultrasound)
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2024to 30 Nov 2025
- 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 without ESRD that initiate CKRT
Who may be able to join
- Adults (≥ 18 years of age)
- Admitted to ICU
- Plan to initiate CKRT by clinician's judgement
Who cannot join
- Refuse to participate
- Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy
- Kidney tran splant recipient
- Receive KRT before ICU admission
- Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease etc.
- Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites.
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- Underlying disease process with a life expectancy less than 90 days
- Pregnancy
- Concomitant severe respiratory distress syndrome
- Expected life expectancy <48 hours
- Receiving extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients (VExLUS-KRT)
Hemodynamic management of critically ill patients has long been focused on the arterial side of the vasculature by assessing adequate perfusion pressure. However, the venous pressure is also of critical importance. Venous congestion can occur in patients with right ventricular failure, pulmonary hypertension or fluid overload. Fluid overload has harmful effects to end organs causing acute kidney injury (AKI), lung edema, multiorgan dysfunction and death. Vice versa, AKI can aggravate fluid retention and inflammation. The measurement of venous pressure usually relies on central venous pressure (CVP) and inferior vena cava diameter (IVC). However, CVP measurement has been associated with measurement errors and has low accuracy in predicting fluid responsiveness. Moreover, IVC collapsibility or distensibility is a static parameter and is associated with subjective variability.
Multiorgan Point-of-Care ultrasound (POCUS) can enhance the management of AKI by enabling the evaluation of renal structural abnormalities and hemodynamic status . POCUS allows the clinician to assess intravascular and pulmonary fluid overload. It has been shown that POCUS is a good parameter to predict global fluid status of the patient .
Venous Excess Ultrasound (VEXUS) consists of the evaluation of IVC, hepatic vein, portal vein and intrarenal vein flow pattern. Previous studies showed significant correlation between VExUS score with RRT-free days and guide fluid management in critically ill patients with AKI . VExUS is useful in predicting patients at risk to develop AKI post cardiac surgery . Adding modified lung ultrasound score to the VExUS protocol could help clinician to adjust fluid administration and achieve proper fluid balance during continuous kidney replacement therapy (CKRT). However, the role of using combined VExUS and lung ultrasound in the assessment and guidance of fluid management during CKRT is unknown.
Read the detailed description
Lung and cardiac ultrasonography can augment the definite diagnosis of volume overload. Thoracic ultrasound demonstrating B-lines which suggest thickened interstitial or fluid filled alveoli or increased vena cava diameter by ultrasound can also be used to assess volume status.
Recently, the venous excess ultrasound grading system (VExUS) has been introduced to be used in conjunction with POCUS to assess significant congestion. This technique used to classify the level of venous congestion by assessing the abdominal blood flow, including hepatic veins (HVs), portal veins (PVs) and intrarenal veins (IRVs). Abnormal patterns of flow in these organs can enhance the clinical evaluation of venous congestion in addition to Inferior vena cava (IVC) ultrasound since organ dysfunction occurring with venous congestion can also be from the transmission of pressure from right atrium (right atrial pressure, RAP) to the peripheral organ. Venous congestion is classified into four grades , ranging from grade 0 (no congestion) to the most severe form, grade 3 (severe congestion) or VExUS "A" through "E".
In the Modified VExUS score, the VExUS grade 0 by IVC cut-off by ≤ 2 cm is replaced with the IVC distensibility index < 18% or the IVC collapsibility index < 50%, depending on patient passive or active ventilation, respectively.
Lung ultrasound and AKI Volume overload is associated with interstitial edema which increases the diffusion distance for oxygen and induces an increase in interstitial fluid pressure, impairing capillary blood flow and exacerbating organ dysfunction . A prospective pilot observational study with 45 adult patients with AKI at any time during ICU stay employed the FALLS (Fluid Administration Limited by Lung Ultrasound) protocol in which they use the LUS for assessing volume status. A new onset of the B-lines was considered as the endpoint of fluid administration. The study demonstrated a linear correlation between baseline B-line scores and PaO2/FiO2 ratio in ICU patients VExUS and lung ultrasound during CKRT
Previous studies have shown that VExUS and lung ultrasound may play a role in predicting AKI severity and may aid fluid de-escalation in critically ill patients. However, no studies have evaluated the role of both VExUS, modified VExUS and lung ultrasound in guiding fluid management during CKRT. Our research aims to evaluate the prevalence of venous congestion by VExUS, mVExUS and lung ultrasound during CKRT and its association with clinical outcomes.
- Conditions
- Acute Kidney Failure Stage 3
- Being tested
- VExUS (venous excess ultrasound), modified VExUS (modified venous excess ultrasound)
- Keywords
- Acute kidney injury, VexLUS, Critically ill, Kidney replacement therapy, Continuous kidney replacement therapy, POCUS, modifiedVExUS
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VExUS (venous excess ultrasound)Diagnostic test
Also called Bioelectrical impedence (BIA), N-terminal pro B-type natriuretic peptide (NT-proBNP), modifiedVExUS
IVC, hepatic veins (HVs), portal veins (PVs) and intrarenal veins (IRVs), and lung ultrasound
modified VExUS (modified venous excess ultrasound)Diagnostic test
replace the IVC maximal diameter cut-off by ≤ 2 cm with the IVC distensibility index < 18% or the IVC collapsibility index < 50%, depending on patient passive or active ventilation, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving CKRT | 1. Adults (≥ 18 years of age)
2. Admitted to ICU
3. Plan to initiate CKRT by clinician's judgement Receives: Diagnostic Test: VExUS (venous excess ultrasound); Diagnostic Test: modified VExUS (modified venous excess ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of venous congestion by using VExLUS and modifiedVExUS in patients who receive CKRT
prevalence of venous congestion
Measured: 1 day
Secondary outcomes (10)
To evaluate the association between VExLUS and modifiedVExUS scores and all-cause mortality within 90 days, KRT-free days, ventilator-free days, vasopressor-free days, ICU-free days, dialysis dependence ay 28 days and 90 days
clinical outcomes
Measured: up to 90 days
- to assess the correlation of VExLUS and modifiedVExUS score with bioelectrical impedance vector analysis (BIVA) parameters and biomarkers
Correlation to BIVA
Measured: 1 day
to evaluate inter-observer variability in determining VExLUS
inter-observer variability
Measured: 3 days
To evaluate the association between VExLUS and modifiedVExUS scores and all-cause mortality within 28 days
28 days all cause mortality
Measured: 28 days
Association between protein-calorie malnutrition and mortality in patients with acute kidney injury (AKI) undergoing continuous renal replacement therapy (CRRT).
To determine the association between protein-calorie malnutrition and mortality in patients with acute kidney injury (AKI) undergoing continuous renal replacement therapy (CRRT).
Measured: 7 days after enrollment
optimal protein and energy supplementation and mortality
To identify the optimal amount of protein and energy supplementation required to reduce mortality.
Measured: From enrollment to the end of treatment at 28 days
Maximum level of protein and energy intake association with clinical outcomes
To determine the maximum levels of protein and energy intake associated with the best clinical outcomes.
Measured: from enrollment upto 28 days
Current prescribed protein and energy in AKI patients during CRRT
To find the current prescribed protein and energy practice in AKI patients during CRRT?
Measured: from enrollment date to 7 days after enrollment
association between energy intake, protein intake and nPCR in AKI patients during CRRT
To find association between energy intake, protein intake and nPCR in AKI patients during CRRT with clinical outcomes.
Measured: from enrollment to 7 days after enrollment
correlation between protein intake and nPCR
To find the correlation between prescribed protein intake and nPCR?
Measured: from enrollment to 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024
- Primary completion20 Nov 2025
- Study completion30 Nov 2025
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 Acute Kidney Failure Stage 3Studies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuttha Lumlertgul, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254703
- Sponsor's protocol ID
- 0899/66
- Acronym
- VExLUS-KRT
- Status last verified
- May 2026
- First submitted
- 28 Jan 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trakarnvanich T, Wannakittirat A, Peerapornratana S, Avihingsanon Y, Ostermann M, Srisawat N, Lumlertgul N. Venous excess and lung ultrasound during continuous renal replacement therapy in critically ill patients (VExLUS-RRT): a prospective observational study. Ann Intensive Care. 2026 Jul 30;16:100129. doi: 10.1016/j.aicoj.2026.100129. eCollection 2026.
PubMed 42602714
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients (VExLUS-KRT)
- ClinicalTrials.gov ID
- NCT06254703
- Acronym / sponsor ID
- VExLUS-KRT / 0899/66
- Conditions
- Acute Kidney Failure Stage 3
- Keywords
- Acute kidney injury, VexLUS, Critically ill, Kidney replacement therapy, Continuous kidney replacement therapy, POCUS, modifiedVExUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Feb 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.
Hemodynamic management of critically ill patients has long been focused on the arterial side of the vasculature by assessing adequate perfusion pressure. However, the venous pressure is also of critical importance. Venous congestion can occur in patients with right ventricular failure, pulmonary hypertension or fluid overload. Fluid overload has harmful effects to end organs causing acute kidney injury (AKI), lung edema, multiorgan dysfunction and death. Vice versa, AKI can aggravate fluid retention and inflammation. The measurement of venous pressure usually relies on central venous pressure (CVP) and inferior vena cava diameter (IVC). However, CVP measurement has been associated with measurement errors and has low accuracy in predicting fluid responsiveness. Moreover, IVC collapsibility or distensibility is a static parameter and is associated with subjective variability.
Multiorgan Point-of-Care ultrasound (POCUS) can enhance the management of AKI by enabling the evaluation of renal structural abnormalities and hemodynamic status . POCUS allows the clinician to assess intravascular and pulmonary fluid overload. It has been shown that POCUS is a good parameter to predict global fluid status of the patient .
Venous Excess Ultrasound (VEXUS) consists of the evaluation of IVC, hepatic vein, portal vein and intrarenal vein flow pattern. Previous studies showed significant correlation between VExUS score with RRT-free days and guide fluid management in critically ill patients with AKI . VExUS is useful in predicting patients at risk to develop AKI post cardiac surgery . Adding modified lung ultrasound score to the VExUS protocol could help clinician to adjust fluid administration and achieve proper fluid balance during continuous kidney replacement therapy (CKRT). However, the role of using combined VExUS and lung ultrasound in the assessment and guidance of fluid management during CKRT is unknown.
Detailed description
Lung and cardiac ultrasonography can augment the definite diagnosis of volume overload. Thoracic ultrasound demonstrating B-lines which suggest thickened interstitial or fluid filled alveoli or increased vena cava diameter by ultrasound can also be used to assess volume status.
Recently, the venous excess ultrasound grading system (VExUS) has been introduced to be used in conjunction with POCUS to assess significant congestion. This technique used to classify the level of venous congestion by assessing the abdominal blood flow, including hepatic veins (HVs), portal veins (PVs) and intrarenal veins (IRVs). Abnormal patterns of flow in these organs can enhance the clinical evaluation of venous congestion in addition to Inferior vena cava (IVC) ultrasound since organ dysfunction occurring with venous congestion can also be from the transmission of pressure from right atrium (right atrial pressure, RAP) to the peripheral organ. Venous congestion is classified into four grades , ranging from grade 0 (no congestion) to the most severe form, grade 3 (severe congestion) or VExUS "A" through "E".
In the Modified VExUS score, the VExUS grade 0 by IVC cut-off by ≤ 2 cm is replaced with the IVC distensibility index < 18% or the IVC collapsibility index < 50%, depending on patient passive or active ventilation, respectively.
Lung ultrasound and AKI Volume overload is associated with interstitial edema which increases the diffusion distance for oxygen and induces an increase in interstitial fluid pressure, impairing capillary blood flow and exacerbating organ dysfunction . A prospective pilot observational study with 45 adult patients with AKI at any time during ICU stay employed the FALLS (Fluid Administration Limited by Lung Ultrasound) protocol in which they use the LUS for assessing volume status. A new onset of the B-lines was considered as the endpoint of fluid administration. The study demonstrated a linear correlation between baseline B-line scores and PaO2/FiO2 ratio in ICU patients VExUS and lung ultrasound during CKRT
Previous studies have shown that VExUS and lung ultrasound may play a role in predicting AKI severity and may aid fluid de-escalation in critically ill patients. However, no studies have evaluated the role of both VExUS, modified VExUS and lung ultrasound in guiding fluid management during CKRT. Our research aims to evaluate the prevalence of venous congestion by VExUS, mVExUS and lung ultrasound during CKRT and its association with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving CKRT | – | Diagnostic Test: VExUS (venous excess ultrasound), Diagnostic Test: modified VExUS (modified venous excess ultrasound)1. Adults (≥ 18 years of age) 2. Admitted to ICU 3. Plan to initiate CKRT by clinician's judgement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients without ESRD that initiate CKRT
Key inclusion criteria (3 listed)
- Adults (≥ 18 years of age)
- Admitted to ICU
- Plan to initiate CKRT by clinician's judgement
Key exclusion criteria (11 listed)
- Refuse to participate
- Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy
- Kidney tran splant recipient
- Receive KRT before ICU admission
- Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease etc.
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 |
|---|---|---|
| VExUS (venous excess ultrasound)Also: Bioelectrical impedence (BIA), N-terminal pro B-type natriuretic peptide (NT-proBNP), modifiedVExUSIVC, hepatic veins (HVs), portal veins (PVs) and intrarenal veins (IRVs), and lung ultrasound | Diagnostic test | Patients receiving CKRT |
| modified VExUS (modified venous excess ultrasound)replace the IVC maximal diameter cut-off by ≤ 2 cm with the IVC distensibility index < 18% or the IVC collapsibility index < 50%, depending on patient passive or active ventilation, respectively. | Diagnostic test | Patients receiving CKRT |
Primary outcome
To assess the prevalence of venous congestion by using VExLUS and modifiedVExUS in patients who receive CKRT
Time frame: 1 day
prevalence of venous congestion
10 secondary outcomes
To evaluate the association between VExLUS and modifiedVExUS scores and all-cause mortality within 90 days, KRT-free days, ventilator-free days, vasopressor-free days, ICU-free days, dialysis dependence ay 28 days and 90 days
Time frame: up to 90 days
- to assess the correlation of VExLUS and modifiedVExUS score with bioelectrical impedance vector analysis (BIVA) parameters and biomarkers
Time frame: 1 day
to evaluate inter-observer variability in determining VExLUS
Time frame: 3 days
To evaluate the association between VExLUS and modifiedVExUS scores and all-cause mortality within 28 days
Time frame: 28 days
Association between protein-calorie malnutrition and mortality in patients with acute kidney injury (AKI) undergoing continuous renal replacement therapy (CRRT).
Time frame: 7 days after enrollment
optimal protein and energy supplementation and mortality
Time frame: From enrollment to the end of treatment at 28 days
Maximum level of protein and energy intake association with clinical outcomes
Time frame: from enrollment upto 28 days
Current prescribed protein and energy in AKI patients during CRRT
Time frame: from enrollment date to 7 days after enrollment
association between energy intake, protein intake and nPCR in AKI patients during CRRT
Time frame: from enrollment to 7 days after enrollment
correlation between protein intake and nPCR
Time frame: from enrollment to 7 days after enrollment
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 8 May 2026.
- Derived from this study: PubMed 42602714Trakarnvanich T, Wannakittirat A, Peerapornratana S, Avihingsanon Y, Ostermann M, Srisawat N, Lumlertgul N. Venous excess and lung ultrasound during continuous renal replacement therapy in critically ill patients (VExLUS-RRT): a prospective observational study. Ann Intensive Care. 2026 Jul 30;16:100129. doi: 10.1016/j.aicoj.2026.100129. eCollection 2026.
- Individual participant dataSharing planned: No
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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 Failure Stage 3, run by Chulalongkorn University at 1 site in Thailand.
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 11 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 8 May 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 Thailand. 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 assess the prevalence of venous congestion by using VExLUS and modifiedVExUS in patients who receive CKRT (time frame: 1 day). 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 NCT06254703, 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 8 May 2026.