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临床试验/EUCTR2010-019740-39-IT
EUCTR2010-019740-39-IT进行中(未招募)不适用

Isotonic contrast (iodixanol) administration vs. low osmolar contrast (iopromide) use: evaluating risk of contrast-induced nephropathy in cancer patients at very low risk - COMEDIANS

ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点开始时间: 2010年4月26日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age at recruitment in an 18 to 70 year range
  • Histologically confirmed cancer diagnosis: we will recruit patients who had received a histologically confirmed cancer diagnosis within a 5-year interval prior to the study entry (prevalent cases) as well as patients diagnosed with any incident, histologically confirmed cancer (incident cases). We will include cancer patients independent of the primitive cancer site (also considering cancers of unknown origin), histological type, stage and grade of cell anaplasia.
  • Very low risk of CIN: we will include cancer patients at very low risk of CIN as defined by a GFR >60 ml/min. To join our study, the GFR assessment has to take place within the 72 hours preceding the CT scan
  • Prior indication to a thorax-abdomen-pelvis CT scan with iodine CM: we will include cancer patients with a pre-scheduled thorax-abdomen-pelvis CT scan assessment, whose indications are totally independent from our study purposes
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Pathological conditions:
  • odiabetes mellitus (both IDDM and NIDDM)
  • ocardio/cerebro-vascular diseases: coronary artery disease, myocardial infarction, uncontrolled/untreated hypertension (that is, a diastolic/systolic blood pressure equal to or greater than 100/140 mm Hg)
  • omulti/polycystic kidney
  • osolitary kidney
  • oacquired immune-deficiency syndrome (AIDS)
  • Previous transplants (any indication, any site)
  • Dehydration or reduction of plasmatic volume (based on the hematocric value)
  • Iodated contrast-media administration in the last 30 days before the exam
  • History of CM hypersensitiveness

研究者

发起方
ISTITUTI FISIOTERAPICI OSPITALIERI

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