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 : March 25, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||3300 participants|
|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 :||June 2020|
|Estimated Study Completion Date :||June 2020|
- Other: No intervention
No interventions will be performed on these patients.
- 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).
- Mortality [ Time Frame: Study frame: 1 year ]Evaluation of the discriminatory power of all the glycemic variability indexes on mortality.
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
|Contact: Abele Donati, MDemail@example.com|
|University ICU, AOU Ospedali Riuniti Ancona||Recruiting|
|Ancona, Marche, Italy, 60126|
|Contact: Abele Donati, MD +390715964603 firstname.lastname@example.org|
|Principal Investigator: Abele Donati, MD|
|Principal Investigator:||Abele Donati, MD||Università Politecnica delle Marche|