Development of Pneumonia Due to Alveolar Glucose Levels i... | NCT03577964

Studies
Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

NCT03577964

Sponsor

University of Ulm

Status

Unknown status

Last Update Posted

Apr 26, 2019Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Glucose Metabolism Disorders
Pneumonia, Bacterial

Interventions

Glucose Measurements,

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Apr 25, 2019Actual

Completion Date

Apr 25, 2020Estimated

First Submitted Date

Jun 7, 2018

First Submission Date that Met QC Criteria

Jun 22, 2018

First Posted Date

Jul 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2019

Last Update Posted Date

Apr 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Kraft MD, MMS, Pricipal Investigator of Clinical Research, Dept of Cardiac, Thoracic and Vascular Surgery, University of UlmPrincipal Investigator

Lead Sponsor

University of UlmOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose Measurements,	Diagnostic Test	Measurement of glucose Levels in bronchio alveolar secretions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving an planned cardiac surgical procedure.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Kraft, MD, MMS	University of Ulm Dept. of Cardiothoracic and Vascular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ulm Dept. of Surgery		Ulm	Baden Wüttemberg	89070	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24074819	Background	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.
14678009	Background

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 1, 2017	Jun 22, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 1, 2017	Jun 22, 2018	SAP_001.pdf

ID	Term
D044882	Glucose Metabolism Disorders
D018410	Pneumonia, Bacterial
D011014	Pneumonia
D007239	Infections
D012141	Respiratory Tract Infections
D006943	Hyperglycemia

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses