Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
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- •subsequently withdrawn consent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
Robert Kraft MD, MMS
Pricipal Investigator of Clinical Research, Dept of Cardiac, Thoracic and Vascular Surgery
University of Ulm
