Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 6
- 主要终点
- Number of participants with major adverse kidney events at 30 days
研究概览
简要总结
Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. The objective of this study is to determine whether ultrasound markers of organ congestion are associated with major adverse kidney events in critically ill patients with severe acute kidney injury.
详细描述
Background: Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a direct mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications.
Objective: To determine whether ultrasound markers of organ congestions are associated with major adverse kidney events and other adverse clinical outcomes.
Study design: A cohort of critically ill patients with a new onset of severe acute kidney injury will undergo repeated ultrasound assessments to detect the presence of the following markers:
- Portal flow pulsatility on pulse-wave Doppler
- Discontinuous intra-renal venous flow on pulse-wave Doppler
- Abnormal hepatic vein waveform on pulse wave Doppler
- Presence of pulmonary B-line artifacts on 2D lung ultrasound
- Presence of dilated and non-collapsible inferior vena cava on 2D ultrasound
- Presence of systolic right ventricular dysfunction
- Presence of systolic left ventricular dysfunction
Clinical outcomes will be collected for up to 90 days after recruitment.
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
- •Admitted to the ICU
- •Women with serum creatinine ≥ 100 µmol/L and men with serum creatinine ≥ 130 µmol/L
- •Severe acute kidney injury (AKI) defined either: A ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization OR achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization OR Urine output < 6.0 mL/kg over the preceding 12 hours OR initiation of renal replacement therapy (RRT) for severe AKI initiated less than 72 hours before recruitment.
排除标准
- •Lack of commitment to provide RRT as part of limitation of ongoing life support. (Operational definition: Critical care team has deemed the patient not to be eligible for escalation of life support, including the initiation of RRT, or substitute decision makers have declined offer of same.)
- •Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 20 mL/min/1.73 m2 in a patient who is not on chronic RRT. (Operational definition: The coordinator will review all documented serum creatinine values within 365 days prior to the date of admission for the current hospitalization. The value closest to the admission date will be considered as the "baseline" and will be used to calculate the corresponding estimated glomerular filtration rate using an online calculator. A value of < 20 mL/min/1.73 m2 derived from the CKD-EPI equation will be grounds for exclusion.
结局指标
主要结局
Number of participants with major adverse kidney events at 30 days
时间窗: 30 days
Either death, receipt of renal replacement therapy or sustained loss of kidney function (new onset of estimated glomerular filtration rate (eGFR) \< 60 or, if pre-existing eGFR \< 60, 25% or greater decline in eGFR)
次要结局
- Number of participants with renal replacement therapy dependence at 30 days(30 days)
- Rate of in-hospital death(30 days)
- Number of participants with sustained loss of kidney function at 30 days(30 days)
- Ventilation-free days through day 30(30 days)
- Number of participants with major adverse kidney events at 90 days(90 days)
- Intensive care unit (ICU)-free days through day 30(30 days)
- Vasopressor-free days though day 30(30 days)
- Rate of death at 90 days(90 days)
- Estimated glomerular filtration rate at 90 days(90 days)