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Relationship Between Blood Glucose Levels and Variability and Infections Development in Critically Ill Patient

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ClinicalTrials.gov Identifier: NCT02659995
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche

Brief Summary:

Our multicenter prospective observational study aims to show the relationship between blood glucose levels and glycemic variability and the development of infections during the ICU stay and with outcome. Within the secondary endpoints, we will evaluate if a blood glucose range between 70 and 140 mg/dl is associated with an increasing surviving rate in non-diabetic critically ill patients.

MATERIALS AND METHODS Multicenter study (ICUs of some Italian University Hospitals). Written informed consent will be request before the inclusion of each patient in the study; if it will not be possible, an informing module will be given to the patient's family and the informed consent will be request to the patients as soon as possible.

Inclusion criteria: 300 patients consecutively admitted in each ICU from January 2016 and not later than 31/12/2018.

Exclusion criteria: age < 18, end-stage disease. Data collection An Excel database will be edited with these data about each patient: age, sex, type I or II diabetes, glycated hemoglobin, at-home antidiabetic therapy; admission diagnosis, admission SAPS II score; daily insulin administration (dose and route of administration, time of start, dose at the moment of glycemic measurement and min-max daily range); steroid therapy (molecule, daily dose, date of start and stop); antibiotic therapy (molecule, daily dose, date of start and stop); daily caloric and protein intake and type of nutrition; other therapies; mechanical ventilation (date of start and stop); blood lactates (worst daily value); daily leucocytes and differential white cells count; daily SOFA score; presence of infections (suspected or confirmed; site and microorganism and eventual Multidrug Resistance pattern); presence of sepsis (following SCCM criteria); length of ICU and hospital stay; outcome (ICU and hospital mortality).

Every blood glucose level measurement obtained will be registered with date and time.

Glycemic variability will be evaluated in terms of:

  • Standard deviation (SD)
  • Mean Amplitude of Glycemic Excursions (MAGE);
  • Coefficient of Variation (CV);
  • Glycemic Lability Index (GLI). STATISTICAL ANALYSIS Data analysis will be performed with Kolmogorov-Smirnov test; parametric and non-parametric s tests, t-test (or Mann-Whitney test), ROC Curve, binary logistic regression. Subgroups analysis.

Statistical significance: p < 0,05. SAMPLE SIZE 3300 patients.


Condition or disease Intervention/treatment
Critical Care Other: No intervention

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Blood Glucose Levels and Variability and Infections Development in Critically Ill Patient
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar


Intervention Details:
  • Other: No intervention
    No interventions will be performed on these patients.


Primary Outcome Measures :
  1. Relationship between Glycemic Lability Index and arise of new infections. [ Time Frame: Study frame: 1 year ]
    Evaluation of the discriminatory power of Glycemic Lability Index (GLI) on infections development with AUC (ROC curve).


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Study frame: 1 year ]
    Evaluation of the discriminatory power of all the glycemic variability indexes on mortality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients consecutively admitted in the participating ICUs.
Criteria

Inclusion Criteria:

  • All the patients admitted in ICU

Exclusion Criteria:

  • age < 18, patients with end-stage disease with life expectancy shorter than 24 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659995


Contacts
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Contact: Abele Donati, MD +390715964603 a.donati@univpm.it

Locations
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Italy
University ICU, AOU Ospedali Riuniti Ancona Recruiting
Ancona, Marche, Italy, 60126
Contact: Abele Donati, MD    +390715964603    a.donati@univpm.it   
Principal Investigator: Abele Donati, MD         
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
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Principal Investigator: Abele Donati, MD Università Politecnica delle Marche

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Responsible Party: Abele Donati, MD, Associate Professor of Anesthesiology, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT02659995     History of Changes
Other Study ID Numbers: GLINF001
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Abele Donati, MD, Università Politecnica delle Marche:
glycemic variability
infection

Additional relevant MeSH terms:
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Infection
Critical Illness
Disease Attributes
Pathologic Processes