Viewing Study NCT06254703



Ignite Creation Date: 2024-05-06 @ 8:06 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06254703
Status: RECRUITING
Last Update Posted: 2024-02-12
First Post: 2024-01-28

Brief Title: Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients
Sponsor: Chulalongkorn University
Organization: Chulalongkorn University

Study Overview

Official Title: Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients VExLUS-KRT
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VExLUS-KRT
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
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 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 PaO2FiO2 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 and lung ultrasound in guiding fluid management during CKRT Our research aims to evaluate the prevalence of venous congestion by VExUS and lung ultrasound VExLUS during CKRT and its association with clinical outcomes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None