Glucose Metabolism DisordersNCT03577964
Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
An observational study of Glucose Metabolism Disorders and Pneumonia, Bacterial, run by University of Ulm at 1 site in Germany.
Trial summary
Incidence of Pneumonia in Patients with high systemic glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Metabolism Disorders, Pneumonia, Bacterial
- What is being tested?
- Glucose Measurements,
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 25 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving an planned cardiac surgical procedure.
Who may be able to join
- 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
Who cannot join
- 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- subsequently withdrawn consent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
Trial locations and contacts
1 site in 1 country.
About this study
Incidence of Pneumonia in Patients with high systemic glucose levels.
Read the 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.
- Conditions
- Glucose Metabolism Disorders, Pneumonia, Bacterial
- Being tested
- Glucose Measurements,
- Keywords
- Pneumonia, Glucose, Infections, Respiratory Tract Infection, Hyperglycemia, Critical Care
- Medical subject headings
- Glucose Metabolism Disorders, Pneumonia, Bacterial, Pneumonia, Infections, Respiratory Tract Infections, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Measurements,Diagnostic test
Measurement of glucose Levels in bronchio alveolar secretions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Sep 2017
- Primary completion25 Apr 2019
- Study completion25 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Kraft MD, MMS, University of Ulm
- Investigators
- Robert Kraft, MD, MMS, Principal investigator, University of Ulm Dept. of Cardiothoracic and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577964
- Sponsor's protocol ID
- 267/17
- Status last verified
- Apr 2019
- First submitted
- 7 Jun 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24074819Wood 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.
PubMed 14678009Kalsi 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.
PubMed 18781323Philips 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.
PubMed 16135681
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
- ClinicalTrials.gov ID
- NCT03577964
- Acronym / sponsor ID
- 267/17
- Conditions
- Glucose Metabolism Disorders, Pneumonia, Bacterial
- Keywords
- Pneumonia, Glucose, Infections, Respiratory Tract Infection, Hyperglycemia, Critical Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2020 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving an planned cardiac surgical procedure.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose Measurements,Measurement of glucose Levels in bronchio alveolar secretions | Diagnostic test | – |
Primary outcome
Incidence of pneumonia or lower respiratory tract infection
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 24074819Kraft 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.
- Background: PubMed 14678009Wood 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.
- Background: PubMed 18781323Kalsi 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.
- Background: PubMed 16135681Philips 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kraft, MD, MMS principal investigator
University of Ulm Dept. of Cardiothoracic and Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism Disorders and Pneumonia, Bacterial, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonia or lower respiratory tract infection (time frame: 20 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577964, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.