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NCT Number: NCT06254703

Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥ 18 years of age)
  • Admitted to ICU
  • Plan to initiate CKRT by clinician's judgement

Exclusion criteria

  • 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.
  • 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)

Treatment and study plan

VExUS (venous excess ultrasound)

Diagnostic Test

IVC, hepatic veins (HVs), portal veins (PVs) and intrarenal veins (IRVs), and lung ultrasound

Other names: Bioelectrical impedence (BIA), N-terminal pro B-type natriuretic peptide (NT-proBNP), modifiedVExUS

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    clinical outcomes

  2. - to assess the correlation of VExLUS and modifiedVExUS score with bioelectrical impedance vector analysis (BIVA) parameters and biomarkers

    Time frame: 1 day

    Correlation to BIVA

  3. to evaluate inter-observer variability in determining VExLUS

    Time frame: 3 days

    inter-observer variability

  4. To evaluate the association between VExLUS and modifiedVExUS scores and all-cause mortality within 28 days

    Time frame: 28 days

    28 days all cause mortality

  5. 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

    To determine the association between protein-calorie malnutrition and mortality in patients with acute kidney injury (AKI) undergoing continuous renal replacement therapy (CRRT).

  6. optimal protein and energy supplementation and mortality

    Time frame: From enrollment to the end of treatment at 28 days

    To identify the optimal amount of protein and energy supplementation required to reduce mortality.

  7. Maximum level of protein and energy intake association with clinical outcomes

    Time frame: from enrollment upto 28 days

    To determine the maximum levels of protein and energy intake associated with the best clinical outcomes.

  8. Current prescribed protein and energy in AKI patients during CRRT

    Time frame: from enrollment date to 7 days after enrollment

    To find the current prescribed protein and energy practice in AKI patients during CRRT?

  9. association between energy intake, protein intake and nPCR in AKI patients during CRRT

    Time frame: from enrollment to 7 days after enrollment

    To find association between energy intake, protein intake and nPCR in AKI patients during CRRT with clinical outcomes.

  10. correlation between protein intake and nPCR

    Time frame: from enrollment to 7 days after enrollment

    To find the correlation between prescribed protein intake and nPCR?

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients (VExLUS-KRT)

Acronym: VExLUS-KRT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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