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

NCT06254703 | Active Not Recruiting

• 1 other identifier: 0899/66
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Kidney Failure Stage 3

Keywords

Acute kidney injury; VexLUS; Critically ill; Kidney replacement therapy; Continuous kidney replacement therapy; POCUS

Outcome Measures

Primary Outcomes (1)

• To assess the prevalence of venous congestion by using VExLUS in patients who receive CKRT

  prevalence of venous congestion

  1 day

Secondary Outcomes (4)

• To evaluate the association between VExLUS 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

  up to 90 days

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

  1 day

• to evaluate inter-observer variability in determining VExLUS

  3 days

• To evaluate the association between VExLUS scores and all-cause mortality within 28 days

  28 days

Study Arms (1)

Patients receiving CKRT

1. Adults (≥ 18 years of age) 2. Admitted to ICU 3. Plan to initiate CKRT by clinician's judgement

Diagnostic Test: VexLUS (venous excess lung ultrasound)

Interventions

VexLUS (venous excess lung ultrasound) DIAGNOSTIC_TEST

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

Also known as: Bioelectrical impedence (BIA), N-terminal pro B-type natriuretic peptide (NT-proBNP)

Patients receiving CKRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients without ESRD that initiate CKRT

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King chula memorial hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)