Time to Excretion of Contrast, a Maastricht Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- time to contrast-free urine.
研究概览
简要总结
Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.
详细描述
The primary aim of the current study is to determine contrast elimination time and % in three groups of patients, (with severely reduced, moderate, and mildly reduced to normal renal function). Secondary aims are to explore whether specific situations/characteristics result in higher probability of delayed elimination of contrast, and whether there is a link between elimination time and adverse post-contrast outcomes (post-contrast incidences of acute kidney injury; post-contrast changes in eGFR within 5 days from baseline; 1-month post-contrast change in eGFR; 1-month post-contrast incidences of eGFR decline >=5 mL/min/1.73m2; 1-month dialysis and mortality).
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
- •eGFR <30 mL/min/1.73m2 in absence of dialysis referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+
- •For each included patient with eGFR <30 mL/min/1.73m2, two matched patients will be included:
- •eGFR 30-59 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR <30 mL/min/1.73m2 participant.
- •eGFR >=60 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR <30 mL/min/1.73m2 participant.
排除标准
- •age <18 years
- •dialysis or pre-dialysis
- •intravascular contrast administration having occurred <30 days before the first baseline sample
- •emergency or intensive care status.
结局指标
主要结局
time to contrast-free urine.
时间窗: 5 days
time to the first contrast-free urine sample from the time of intravascular iodinated contrast administration. Time to contrast-free urine will be compared between three groups of patients (with eGFR \<30 mL/min/1.73m2, eGFR 30-59 mL/min/1.73m2, and eGFR \>=60 mL/min/1.73m2).
次要结局
- % contrast elimination.(5 days)
- contrast elimination versus adverse post-contrast outcomes.(1 month)