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临床试验/EUCTR2022-001393-58-NL
EUCTR2022-001393-58-NL进行中(未招募)1 期

POMPAE trial: Peri-Operative Magnesium infusion to Prevent Atrial fibrillation Evaluated.

Hagaziekenhuis0 个研究点目标入组 530 人开始时间: 2022年4月16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)
入组人数
530

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

  • - Elective cardiac surgery (valve surgery and/or CABG)
  • - 18 years and above
  • 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 530
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 530

排除标准

  • History of atrial fibrillation (AF) or atrial flutter
  • - Concomitant rhythm associated procedures (MAZE (surgical
  • ablation)/PVI (pulmonary vein isolation))
  • - Pre-existing severe renal impairment (eGFR<30 ml/min) or
  • development of oliguria post-surgery (<200 ml in previous 6 hours)
  • and/or rise in creatinine with eGFR <30 ml/min)
  • - Significant hypotension persisting for 1 hour or longer (Noradrenaline
  • XML File Identifier: DaOEpsK5SKgBJpVIZW0BQzKReAI=
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  • >0.1 mcg/kg/min)
  • - Development of third-degree heart block during index admission or
  • pre-existing 3rd degree heart block without pacemaker presence.

研究者

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