EUCTR2007-000229-23-FR进行中（未招募）1 期
RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GUERBET
- 入组人数
- 134
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
- •·Male or female, aged = 55 years;
- •·Patient presenting with a known stable stage III to stage IV renal insufficiency according to the K/DOQI definition, i.e., 15 < estimated GFR < 60 ml/min/1.73m² according to MDRD formula for 2 consecutive values (within 10% of each other) obtained over at least one week apart with the most recent value having been obtained within 24 hours prior to the study procedure;
- •·Patient scheduled to undergo a contrast enhanced MR Angiography or unenhanced MRI examination to specify a diagnosis;
- •·Patient able to understand and provide written informed consent to participate in the trial;Patient for whom blood samples can be obtained in the 24 hours preceding the procedure and 72 hours after the examination.
- •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
- •·Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, metallic joint replacement or others according to the imaging laboratory's standard practice);
- •·Patient who has a diagnosis of a hemodynamic instability (cardiogenic shock – persistent systolic pressure < 90 requiring inotropic support) or acute myocardial infraction within 15 days prior the inclusion;
- •·Patient who needs hemodialysis;
- •·Patient with known allergy to gadolinium chelates (only applicable for patient undergoing Dotarem-enhanced MRA);
- •·Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level (i.e. selective inhibitors of cyclo-oxygenase 2, anti-Vascular Endothelium Growth Factors, Vancomycine, Aciclovir, aminoglycosides, amphotericin B, polymixin, platinium complexes and non-steroidal anti-inflammatory treatment except Acetyl Salicylic Acid) within 24 hours before first blood sample and during 72 hours after the procedure;
- •·Patients for whom the dosage of diuretic has been modified during the month prior the inclusion or should be modified during the 3 days after the imaging procedure
- •·Patients planned to either undergo surgery or receive chemotherapy within 72 hours post-procedure (i.e: before the blood test 72 hours post-procedure);
- •·Patient having an imaging procedure (with contrast media or not ) within 7 days of entering this protocol;
- •·Patient with a planned imaging procedure (with contrast media or not ) within 72 hours post-procedure;
- •·Patient with newly discovered unstable diabetes;
研究者
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