Clinical trial NCT03577964: Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
Official title: Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glucose Metabolism Disorders
Pneumonia, Bacterial
Keywords: Pneumonia
Glucose
Infections
Respiratory Tract Infection
Hyperglycemia
Critical Care
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving an planned cardiac surgical procedure.

Brief summary: Incidence of Pneumonia in Patients with high systemic glucose levels.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of pneumonia or lower respiratory tract infection
timeFrame: 20 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm Dept. of Surgery
state: Baden Wüttemberg
Study officials:
affiliation: University of Ulm Dept. of Cardiothoracic and Vascular Surgery
name: Robert Kraft, MD, MMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraft R, Herndon DN, Mlcak RP, Finnerty CC, Cox RA, Williams FN, Jeschke MG. Bacterial respiratory tract infections are promoted by systemic hyperglycemia after severe burn injury in pediatric patients. Burns. 2014 May;40(3):428-35. doi: 10.1016/j.burns.2013.07.007. Epub 2013 Sep 25.
citation: Wood DM, Brennan AL, Philips BJ, Baker EH. Effect of hyperglycaemia on glucose concentration of human nasal secretions. Clin Sci (Lond). 2004 May;106(5):527-33. doi: 10.1042/CS20030333.
citation: Kalsi KK, Baker EH, Fraser O, Chung YL, Mace OJ, Tarelli E, Philips BJ, Baines DL. Glucose homeostasis across human airway epithelial cell monolayers: role of diffusion, transport and metabolism. Pflugers Arch. 2009 Mar;457(5):1061-70. doi: 10.1007/s00424-008-0576-4. Epub 2008 Sep 10.
citation: Philips BJ, Redman J, Brennan A, Wood D, Holliman R, Baines D, Baker EH. Glucose in bronchial aspirates increases the risk of respiratory MRSA in intubated patients. Thorax. 2005 Sep;60(9):761-4. doi: 10.1136/thx.2004.035766.