Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

NCT ID: NCT03577964

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-04-25

Brief Summary

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Incidence of Pneumonia in Patients with high systemic glucose levels.

Detailed Description

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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.

Conditions

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Glucose Metabolism Disorders Pneumonia, Bacterial

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Glucose Measurements,

Measurement of glucose Levels in bronchio alveolar secretions

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Robert Kraft MD, MMS

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Kraft, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

University of Ulm Dept. of Cardiothoracic and Vascular Surgery

Locations

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University of Ulm Dept. of Surgery

Ulm, Baden Wüttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24074819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14678009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18781323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16135681 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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267/17

Identifier Type: -

Identifier Source: org_study_id

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