Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CEUS Measurement9
研究概览
简要总结
The goal of this study is the non-invasive visualization and quantification of renal microvascular dynamics in adult kidneys with proteinuria and/or active sediment.
详细描述
In this study, the microvascular architecture of the kidney in adults with active urinary sediment or proteinuria is to be examined non-invasively using Ultrasound Localization Microscopy (ULM).
Kidney diseases can broadly be classified according to the affected nephron compartment into glomerular, tubular, and tubulointerstitial diseases. Glomerular diseases include, among others, the nephrotic and nephritic syndromes, which differ in their clinical and laboratory characteristics: while the nephrotic syndrome is typically characterized by marked proteinuria (>3.5 g/day), hypoalbuminemia, edema, and hyperlipidemia, the nephritic syndrome is dominated by hematuria with acanthocytes, mild to moderate proteinuria, arterial hypertension, and impaired renal function. Tubular and tubulointerstitial diseases, on the other hand, often manifest as acute kidney injury (e.g., in ischemic or toxic injury), polyuria, salt wasting, or metabolic acidosis, often accompanied by nonspecific symptoms such as fatigue or dehydration.
In addition to these classical nephron compartments, renal vascular structures may also be primarily or secondarily affected, as in vasculitis, thrombotic microangiopathies, or hypertensive nephropathy. Although these vascular structures are not directly part of the nephron, they are functionally closely linked to it and have a significant impact on renal function.
To assess kidney status, pathophysiology, and the site of injury non-invasively, urinary sediment is analyzed. Urinary sediment represents a central diagnostic tool that provides information on the localization of kidney damage, thereby functioning as a type of "liquid biopsy."
If there is clinical suspicion of acute or rapidly progressive renal failure, nephrotic syndrome, significant non-nephrotic proteinuria, glomerular hematuria, or if a systemic disease with possible renal involvement is present, a kidney biopsy is usually indicated for further diagnostic clarification. Obtaining tissue samples for histological examination is an invasive procedure associated with inpatient hospitalization, considerable burden for patients, and potential complications. Currently, alternative imaging methods cannot replace kidney biopsy. Furthermore, CT, PET, or MR imaging is associated with radiation exposure or considerable additional effort (e.g., sedation).
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
- •Age ≥ 18 years
- •Evidence of active urinary sediment and/or proteinuria >1 g/g creatinine
- •Indication for kidney biopsy as part of study-independent diagnostics
- •Written informed consent
排除标准
- •Known allergic disposition to SonoVue®
- •Contraindication to the use of SonoVue®
- •Pregnancy
- •Breastfeeding mothers
研究组 & 干预措施
Study group
Patients with active sediment and/or proteinuria (>1g/g Krea) and indication for renal biopsy
结局指标
主要结局
CEUS Measurement9
时间窗: Baseline and up to 10 weeks after baseline
WoAUC (Wash-out AUC (AUC(TTP:TO)))
CEUS Time intensity curves
时间窗: baseline and up to 10 weeks after baseline
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
CEUS Measurement1
时间窗: baseline and up to 10 weeks after baseline
PE (Peak-Enhancement) is an established measurement in CEUS analysis. It describes the highest signal intensity after administration of contrast agents and is measured in arbitrary units. All CEUS measurements are established measurements in Time intensity analysis (TIC) of contrast enhanced ultrasound data.
CEUS Measurement2
时间窗: Baseline and up to 10 weeks after baseline
Description: WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
CEUS Measurement 3
时间窗: Baseline and up to 10 weeks after baseline
RT (Rise Time = arterial inflow until maximum signal intensity), measured in seconds, higer RT means faster arterial inflow
CEUS Measurement5
时间窗: Baseline and up to 10 weeks after baseline
mTT (mean Transit Time local) (mTT-TI))
CEUS Measurement6
时间窗: Baseline and up to 10 weeks after baseline
TTP (Time to Peak)
CEUS Measurement7
时间窗: Baseline and up to 10 weeks after baseline
WiR (Wash-in-Rate )
CEUS Measurement8
时间窗: Baseline and up to 10 weeks after baseline
WiPI (Wash-in Perfusion Index (WiAUC/RT))
CEUS Measurement10
时间窗: Baseline and up to 10 weeks after baseline
WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))
CEUS Measurement11
时间窗: Baseline and up to 10 weeks after baseline
FT (Fall Time - (TO-TTP))
CEUS Measurement12
时间窗: Baseline and up to 10 weeks after baseline
WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)
CEUS Measurement13
时间窗: Baseline and up to 10 weeks after baseline
QOF (Quality Of Fit between the echo-power signal and f(t)
Visualization and quantification of kidney perfusion with CEUS
时间窗: Baseline and up to 10 weeks after baseline
CEUS imaging for kidney perfusion in kidney disease
Visualization and quantification of kidney mikrovaskularisation with ULM
时间窗: Baseline and up to 10 weeks after baseline
ULM imaging for kidney perfusion and microvaskularisation in kidney disease
Visualization and quantification of glomeruli in the kidney with ULM
时间窗: Baseline and up to 10 weeks after baseline
ULM imaging for glomeruli in the kidney
次要结局
- Assessment of renal function urea(Baseline and up to 10 weeks after baseline)
- ULM and Ultrasound(Baseline and up to 10 weeks after baseline)
- ULM and CEUS(Baseline and up to 10 weeks after baseline)
- ULM and biopsy(Baseline and up to 10 weeks after baseline)
- 2D and 3D ULM(Baseline and up to 10 weeks after baseline)
- ULM and diagnosis(Baseline and up to 10 weeks after baseline)
- Comparison before and after treatment(Baseline and up to 10 weeks after baseline)
- Correlation between ULM and laboratory parameters(Baseline and up to 10 weeks after baseline)
- ULM on different diagnoses(Baseline and up to 10 weeks after baseline)
- Assessment of renal function GFR(Baseline and up to 10 weeks after baseline)
研究者
Ferdinand Knieling
PD Dr. med. Dr. rer. biol. hum. Ferdinand Knieling MHBA
University of Erlangen-Nürnberg Medical School
