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临床试验/NCT04900779
NCT04900779Unknown不适用

Prospective Observational Study to Evaluate Glycocalyx Alteration in Major Abdominal and Thoracic Surgery

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2021年2月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
117
试验地点
1
主要终点
plasmatic syndecan -1 levels

研究概览

简要总结

Background:

The glycocalyx is a fundamental component of the endothelial barrier and alterations at this level have been shown to exacerbate the inflammatory response in the microcirculation. Its degradation in the surgical patient, has been tested in interventions that involve regional or general ischemia, for example in cardiac surgery, major vascular surgery or transplantation. On interventions that do not involve ischemic events the literature is limited, such is the case of those patients undergoing major abdominal and thoracic surgery.

Objective:

Assess whether there is a glycocalyx degradation in major elective abdominal and thoracic surgery, measured as an increase in plasma syndecane-1 levels during the first 24 hours of postoperative care.

Methodology:

Prospective observational study in patients undergoing major elective thoracic and abdominal surgery at the University Hospital Vall d´Hebrón. Measurement of the syndecane-1 plasma levels are going to be done during the first 24 hours after the intervention. It is intended to evaluate whether its elevation is related to anesthetic perioperative factors, and if it has an impact con morbildity and mortality in the following 6 months after the procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years old
  • Patients that are scheduled to major abdominal and thoracic elective surgery in Universtity Hospital Vall d´ Hebrón.
  • Patients ASA I, II and III.
  • Patients that after the intervention have their recovering in the Surgical ICU

排除标准

  • Patients ASA IV and V.
  • Patients that are hospitilized previous to the surgery.
  • Patients that undergo emergent surgery.
  • Patients with Chronic or Acute Renal Failure previous to the surgery.
  • Patients with past medical history of autoinmune disseases.
  • Patients with an active infection previous to the surgery.
  • Patients in treatment with steroids previous to the surgery

结局指标

主要结局

plasmatic syndecan -1 levels

时间窗: In the first 24 hours after the procedure

Degradation of glucocalix measured by plasmatic syndecan -1 levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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