跳至主要内容
临床试验/NCT03577964
NCT03577964Unknown不适用

Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

University of Ulm1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
61
试验地点
1
主要终点
Incidence of pneumonia or lower respiratory tract infection

研究概览

简要总结

Incidence of Pneumonia in Patients with high systemic glucose levels.

详细描述

Clinical and mechanistic studies have shown that a hyperglycaemic metabolic condition is associated with a higher incidence of infection and consecutive increased morbidity and mortality. The underlying mechanisms in detail are not completely understood. So far it is not clear whether systemic increased glucose levels are caused by a stress reaction of the body through a catabolic metabolism situation as well as a "stress-induced insulin resistance", or infections are promoted by hyperglycemia. From in vivo and in vitro studies, a glucose threshold for the lung is known (147 mg / dL), similar to that in the kidney. It can be hypothesized, that an intra-alveolar glucose in turn promotes bacterial growth as a nutrient substrate. The aim of the study is to determine the concentration of glucose in the alveolar space in connection with hyperglycemic conditions, and to demonstrate a higher incidence of pneumonia in this patient group. The study will enroll cardiac surgery patients receiving surgical treatment and expected postoperative ventilation. Systemic blood glucose monitoring is recorded throughout hospitalization, as well as the removal of bronchial aspirates intraoperatively and during ventilation to measure glucose levels and bacterial levels. The incidence of pneumonia is recorded during the postoperative period by means of radiological examinations and / or microbiological examinations.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •women and men over the age of 18 years
  • •voluntary consent to study participation of the patient
  • •Planned cardiac surgery with expected endotracheal ventilation of ≥ 1 day postoperatively

排除标准

  • •age <18 years
  • •pregnancy
  • •Non-able-bodied patients (disempowerment / loss of consciousness, limitation of the ability to express one's own will, for example through disability)
  • •subsequently withdrawn consent
  • •accommodation in an institution on the basis of official or court orders
  • •lack of or insufficient knowledge of German language, whereby the understanding of the written patient education is not guaranteed.
  • •Immunosuppressed patients
  • •Patients with a malignant disease

结局指标

主要结局

Incidence of pneumonia or lower respiratory tract infection

时间窗: 20 days post surgery

The incidence of pneumonia or lower respiratory tract infection will be determined by chest x-ray, CT-Scan and/or sampling of specimens of the lower tract of the airways.

次要结局

未报告次要终点

研究者

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

Robert Kraft MD, MMS

Pricipal Investigator of Clinical Research, Dept of Cardiac, Thoracic and Vascular Surgery

University of Ulm

研究点 (1)

Loading locations...

相似试验