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临床试验/NCT04058496
NCT04058496已完成不适用

The Importance of Wnt-signaling in the Pathobiology of Systemic Inflammation and Organ Dysfunction After Cardiac Surgery

Alain Rudiger1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年11月1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
Alain Rudiger
入组人数
64
试验地点
1
主要终点
Plasma concentration of sFRP1 (ng/ml)

研究概览

简要总结

Cardiac surgery saves lives when patients suffer from cardiac disease. Local inflammation is important for tissue repair and wound healing after such an operation. Inflammation starts already when the patient is treated in the intensive care unit. When inflammatory proteins (cytokines) are released into the circulation, they cause also a systemic inflammation, which alerts the immune system of the body and activates defence mechanisms (=adaptive response). In some patients, systemic inflammation is out of control thereby causing organ dysfunctions, shock, and in the most severe cases even death (=maladaptive response). The aim of this study is to investigate the early phase of inflammation after the operation. Repeated blood samples will be taken of patients undergoing cardiac surgery to describe the patterns and dynamics of inflammation proteins. A better understanding of these mechanisms will potentially lead to improved treatment of patients after cardiac surgery.

详细描述

The aim of this project is to understand early inflammation mechanisms after cardiac surgery. Therefore, repeated blood samples of patients undergoing cardiac surgery will be taken. Patients are selected after "open" cardiac surgery (via sternotomy), when when they require postoperative care in the cardiovascular intensive care unit. The blood samples will be analysed in collaboration with the Inflammation Research Unit of the Department of Internal Medicine at the University Hospital Zurich.

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

  • Cardiac surgery via sternotomy
  • Coronary-bypass bypass surgery with or without valve surgery
  • Postoperative hospitalisation in the cardio-surgical ICU
  • Available informed consent

排除标准

  • Preoperative infections (e.g. endocarditis)
  • Preoperative use of steroids or other immunosuppression

结局指标

主要结局

Plasma concentration of sFRP1 (ng/ml)

时间窗: Up to 48 hours after ICU admission

Measured by a commercially available ELISA

Plasma concentration of sFRP5 (ng/ml)

时间窗: Up to 48 hours after ICU admission

Measured by a commercially available ELISA

Plasma concentration of Wnt5a (ng/ml)

时间窗: Up to 48 hours after ICU admission

Measured by a commercially available ELISA

Plasma concentration of WIF-1 (pg/ml)

时间窗: Up to 48 hours after ICU admission

Measured by a commercially available ELISA

次要结局

  • Length of ICU stay (days)(Up to 4 weeks)
  • Daily fluid balance (ml)(Up to 48 hours after ICU admission)
  • Occurrence of complications (yes/no): composite endpoint of hemodynamic instability (defined as norepinephrine concentration = or > 0.1mcg/kg/min), delirium (defined as ICDSC score = or > 4), infections(Up to 7 days after ICU admission)

研究者

发起方
Alain Rudiger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alain Rudiger

Prof. Dr. med.

University of Zurich

研究点 (1)

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