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临床试验/NCT03468803
NCT03468803已完成不适用

Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Levels of Beta D Glucan after surgery

研究概览

简要总结

Candida species are both known to colonize physiologically mucosal surfaces in the human body without causing signs or symptoms of infection and to cause a wide variety of diseases, including mucocutaneous infections and potentially fatal invasive infections of the bloodstream or organs. Throughout the past decades, invasive fungal infections (IFIs) are of increasing importance even in non-neutropenic patients who are in need of treatment in intensive care units (ICU) or have undergone major surgeries. Several factors like parenteral nutrition, central venous catheters, broad spectrum antibiotics admission, disturbance of gastrointestinal mucosa integrity have been associated with an increased incidence of IFIs. Positive testing for 1,3-ß-D-Glucan (BDG) in serum is widely used to assess invasive fungal infections. It detects circulating BDG, which is part of the fungal cell wall of clinical relevant fungi such as Candida spp. and Aspergillus spp..

The issue of BDG kinetics after intestinal mucosal damage (e.g. mucositis or gut surgery) is poorly understood. Intestinal mucosal damage is characterized by a loss of integrity of the intestinal mucosal barrier and increasing translocations of bacterial and/or fungal commensals of the gastrointestinal tract.

In abdominal surgery a key concern in serum BDG kinetics is the potential introduction of BDG from surgical sponges and gauze or mucosal damage due to surgical damage of the mucosal integrity. Compared to open abdominal surgery in laparoscopic abdominal surgery sponges and gauze are rarely used. As life-threatening intraabdominal candidiasis occurs in 30 to 40% of high-risk abdominal surgical intensive care unit (ICU) patients it is of utmost importance to obtain reliable BDG values for diagnosis or exclusion of invasive candidiasis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Elective open abdominal surgery involving the small and/or large colon and with surgical sectioning of intestinal mucosa
  • Signed informed consent

排除标准

  • Ongoing antifungal therapy for treatment of active fungal infection or antifungal therapy within 4 weeks prior to inclusion
  • Antibiotic therapy other than optional single shot surgical prophylaxis as clinically indicated
  • Ongoing Enterococcus sp. bacteremia or treatment of Enterococcus sp. bacteremia within 4 weeks prior to inclusion
  • Clinical or radiological or laboratory evidence of current infectious disease (i.e. temperature >38°C, elevated C-reactive protein (CRP) >5mg/dl, leukocytosis >11400/μl, elevated neutrophiles >78%) as assessed by the treating physician
  • Immunoglobulin, blood or blood products (i.e. thrombocytes, fresh frozen plasma) administration within 4 weeks prior to inclusion
  • Abdominal surgery (laparoscopic or open) or other major surgeries (e.g. aortocoronary bypass) within 4 weeks prior to inclusion
  • Subsequent invasive candidiasis (defined according to proposed European Organization for Research and Treatment of Cancer Mycoses study group [EORTC/MSG] definitions of fungal infections in ICU) or other complicating infectious disease after surgery within the 5 day observation time frame

研究组 & 干预措施

Beta D Glucan (BDG) in surgery

Experimental

Serial Beta D Glucan measurements in each patients before, during, and after surgery

干预措施: Beta D Glucan test (Diagnostic Test)

结局指标

主要结局

Levels of Beta D Glucan after surgery

时间窗: after surgery up to day 5

Measurement of Beta D Glucan after surgery in pg/ml

次要结局

未报告次要终点

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Krause, MD

Univ.Prof.Dr.

Medical University of Graz

研究点 (2)

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