Current partner codePEPTIDESDE
NCT06254703·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DIAGNOSTIC_TEST

VExUS (venous excess ultrasound)

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

DIAGNOSTIC_TEST

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.

Timeline

From registration to results.

  1. First posted

    Feb 12, 2024

  2. Study start

    Mar 1, 2024

  3. Primary completion

    Nov 20, 2025

  4. Study completion

    Nov 30, 2025

  5. Results posted

    Not reported

  6. Registry updated

    May 8, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

- 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

to evaluate inter-observer variability in determining VExLUS

Time frame · 3 days

inter-observer variability

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

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).

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.

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.

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?

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.

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?

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Adults (≥ 18 years of age) 2. Admitted to ICU 3. Plan to initiate CKRT by clinician's judgement Exclusion Criteria: 1. Refuse to participate 2. Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy 3. Kidney tran splant recipient 4. Receive KRT before ICU admission 5. Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease etc. 6. Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites. 7. Underlying disease process with a life expectancy less than 90 days 8. Pregnancy 9. Concomitant severe respiratory distress syndrome 10. Expected life expectancy \<48 hours 11. Receiving extracorporeal membrane oxygenation (ECMO)

Study locations

1 registered sites.

Thailand. Showing up to 24 locations stored in the fast local snapshot.

King chula memorial hospital

Bangkok, Bangkok, Thailand

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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