EUCTR2021-003172-13-NL进行中（未招募）1 期
The renal and metabolic outcomes after sodium-glucose cotransporter 2 inhibitor in cardiac surgery – an open-label phase IV randomized controlled trial - The MERCURI trial
Amsterdam UMC0 个研究点目标入组 80 人开始时间: 2021年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •18 to 90 years old (inclusive)
- •Undergoing elective cardiac surgery with cardio-pulmonary bypass.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Current treatment with SGLT2 inhibitors.
- •Diabetes Mellitus Type 1
- •BMI<25 for people with type 2 diabetes
- •Reduced renal function at baseline with eGFR < 30 ml/min.
- •Systolic blood pressure < 100 mmHg at time of inclusion.
- •Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. S1-4” according to the Amsterdam UMC classification.
- •Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
- •Known or suspected allergy to trial products or other drugs in the same class.
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