EUCTR2022-002453-25-NL招募中1 期
Preoperative sodium glucose cotransporter 2 inhibitors for prevention of postoperative acute kidney injury in cardiac surgery patients – a randomized, placebo-controlled, multi-centre, phase IV clinical trial - proMoting Effective Renoprotection in Cardiac sURgery patients by SGLT2- Inhibitors
Amsterdam UMC0 个研究点目标入组 784 人开始时间: 2023年2月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 784
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. > 18 years old
- •2. Undergoing elective cardiac surgery.
- •3. Providing informed consent
- •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 392
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 392
排除标准
- •1. Current treatment with SGLT2 inhibitors
- •2. Reduced kidney function at baseline with eGFR < 20 ml/min at time of inclusion
- •3. Diabetes Mellitus Type 1
- •4. History of diabetic keto acidosis
- •5. Diabetes Mellitus Type 2 with BMI<25 for people with type 2 diabetes who are using multiple daily insulin injections (both short and long-acting insulin)
- •6. Systolic blood pressure < 100 mmHg at time of inclusion
- •7. Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. S1-4” according to the Amsterdam UMC classification
- •8. Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- •9. Known or suspected allergy to trial products or other drugs in the same class
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