NCT06285526已完成不适用
Evaluation of Perioperative Glycocalyx Monitoring in Major Abdominal Surgery
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年7月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Glycocalyx thickness
研究概览
简要总结
The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.
详细描述
This monitoring is possible in real time and real conditions by micro-camera GlycoCheck™ (Microvascular Health Solutions Inc., Salt Lake City, Utah, USA), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the HIPEC group :
- •Adult patients
- •Age < 75 years
- •Receiving HIPEC for primary or secondary peritoneal carcinosis
- •For the CDP group :
- •Adult patient
- •Age < 75 years
- •Receiving CDP for pancreatic neoplasia
- •Patient who has read and understood the information letter and does not object to taking part in the study
- •Patient affiliated to a social security scheme
排除标准
- •Secondary distant peritoneal metastases
- •Chronic heart failure
- •Chronic liver failure at stage C of the Child-Pugh score
- •Stage IV or V chronic renal failure
- •Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation
- •Patient refusal
- •Person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship
结局指标
主要结局
Glycocalyx thickness
时间窗: between the day before the operation (Day -1) and the post-operative period (Day 1)
Perioperative variation in glycocalyx thickness (µm)
次要结局
- Glycocalyx thickness and a biological marker of tissue hypoperfusion(post-operative period (Day 1))
- Glycocalyx thickness and a biological marker of tissue hypoxia(post-operative period (Day 1))
- Blood cell velocity and macrocirculatory function(post-operative period (Day 1))
- Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1(between Day -1 and Day 1)
- Perfused capillary density and macrocirculatory function(post-operative period (Day 1))
研究者
研究点 (2)
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