DRKS00027085已完成未知
Evaluation of the performance and safety of the intravascular ivCGM continuous glucose monitoring system in hospitalized patients in critical care units - ivCGM-P2
A. Menarini Diagnostics S.r.l.0 个研究点目标入组 35 人开始时间: 2021年11月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Hospitalized patients in cardiac surgery ICU.
- •2. Age >18 years
- •3. An understanding of and willingness to follow the study protocol and sign the informed consent
- •4. At least 10, maximum 20 with type 1 or type 2 diabetes
排除标准
- •1. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •2. Any serious medical conditions or disability which, in the opinion of the investigator, would interfere with treatment or assessment or would preclude completion of the study
- •3. Pregnancy or breastfeeding
- •4. History of bleeding disorder
- •5. History of heparin-induced thrombocytopenia (HIT)
- •6. Significant acute or chronic illness that might interfere with patient safety or integrity of results as judged by the Investigator
- •7. Anemia with Hb < 7.5 g/dL
- •8. Known hypersensitivity to Fondaparinux sodium (Arixtra®)
- •9. Patient currently participating in an investigational clinical study that interferes with the execution of the study.
- •10. Absence of suitable vein for iv catheter and Probe insertion, as judged by the Investigator: (cephalic vein highly recommended; median antebrachial vein to be avoided; other veins to be chosen at Investigator’s discretion)
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