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临床试验/NCT06254703
NCT06254703已完成不适用

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

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
To assess the prevalence of venous congestion by using VExLUS and modifiedVExUS in patients who receive CKRT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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
  • •Concomitant severe respiratory distress syndrome
  • •Expected life expectancy <48 hours
  • •Receiving extracorporeal membrane oxygenation (ECMO)

研究组 & 干预措施

Patients receiving CKRT

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

干预措施: VExUS (venous excess ultrasound) (Diagnostic Test)

Patients receiving CKRT

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

干预措施: modified VExUS (modified venous excess ultrasound) (Diagnostic Test)

结局指标

主要结局

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

时间窗: 1 day

prevalence of venous congestion

次要结局

  • to evaluate inter-observer variability in determining VExLUS(3 days)
  • 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(up to 90 days)
  • - to assess the correlation of VExLUS and modifiedVExUS score with bioelectrical impedance vector analysis (BIVA) parameters and biomarkers(1 day)
  • To evaluate the association between VExLUS and modifiedVExUS scores and all-cause mortality within 28 days(28 days)
  • Association between protein-calorie malnutrition and mortality in patients with acute kidney injury (AKI) undergoing continuous renal replacement therapy (CRRT).(7 days after enrollment)
  • optimal protein and energy supplementation and mortality(From enrollment to the end of treatment at 28 days)
  • Maximum level of protein and energy intake association with clinical outcomes(from enrollment upto 28 days)
  • Current prescribed protein and energy in AKI patients during CRRT(from enrollment date to 7 days after enrollment)
  • association between energy intake, protein intake and nPCR in AKI patients during CRRT(from enrollment to 7 days after enrollment)
  • correlation between protein intake and nPCR(from enrollment to 7 days after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuttha Lumlertgul, MD

Principal investigator

Chulalongkorn University

研究点 (1)

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