跳至主要内容
临床试验/NCT03918824
NCT03918824已完成不适用

Retrospective Analysis of the Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.

Agnieszka Pozdzik1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,000
试验地点
1
主要终点
Body mass

研究概览

简要总结

Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the treatment.

For the vast majority of the population, exposure to ICP is perfectly well tolerated. Nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (NIC). NIC is the third cause of an acquired acute renal failure within the hospital.It significantly increases morbidity and mortality and prolongs the hospital stay.

Of all the procedures requiring ICP administration, PCI is associated with the highest rate of NIC.This evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.Age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing NIC.

Nowadays, the use of PCI in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. This is linked to the aging of the population and the increasing incidence of cardiovascular diseases.

ICP-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.These intra-renal mechanisms lead to an acute renal function impairment.NIC is defined as an increase of serum creatinemia ≥ 0.5 mg / dL (or a 25% increase) from the baseline in the 48-72h following PC injection with no other obvious etiology. It reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days.

The prevention of NIC based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). In contrast, there is little data on the relationship between NIC and the PCI volume used. To the investigator's knowledge, the threshold of toxic volume is not well defined. Taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an ICP and the occurrence of a NIC according to the criteria mentioned above.

研究设计

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

入排标准

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

入选标准

  • All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013
  • Access to extensive demographic, clinical and biological data

排除标准

  • 未提供

结局指标

主要结局

Body mass

时间窗: 1 day

Body mass

Creatinin rate

时间窗: 10 days after PCI

Creatinin rate

Glomerular filtration rate

时间窗: 10 days after PCI

Glomerular filtration rate

incidence of nephropathies induced by the injection of iodinate contrast medium

时间窗: 7 years

incidence of nephropathy induced by injection of contrast medium

Volume of iodinated contrast medium injected

时间窗: 1 day

Volume of iodinated contrast medium injected

Urea concentration

时间窗: 10 days after PCI

Urea concentration

次要结局

  • Existence of risk factors (yes/no)(7 years)
  • Glomerular filtration rate(1 year after PCI)
  • Urea concentration(1 year after PCI)
  • Creatinin rate(1 year after PCI)

研究者

发起方
Agnieszka Pozdzik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Agnieszka Pozdzik

Head of nephro-dialysis clinic

Brugmann University Hospital

研究点 (1)

Loading locations...

相似试验

Influence of Iodinated Contrast Volume Injected... | 临床试验