Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

Glucose Metabolism Disorders Clinical Trial

Official title:

Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03577964
• Other study ID #: 267/17
• Status: Active, not recruiting
• Start date: September 1, 2017
• Est. completion date: April 25, 2020

Study information

• Verified date: April 2019
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Incidence of Pneumonia in Patients with high systemic glucose levels.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: April 25, 2020
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hyperglycemia
• Metabolic Diseases
• Pneumonia
• Pneumonia, Bacterial

Intervention

Diagnostic Test:
• Glucose Measurements,
Measurement of glucose Levels in bronchio alveolar secretions

Locations

Country	Name	City	State
Germany	University of Ulm Dept. of Surgery	Ulm	Baden Wüttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pneumonia or lower respiratory tract infection	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.	20 days post surgery