MedTrace Logo

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

NCT02659995 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3300

Last updated 2020-03-25

No results posted yet for this study

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.

Conditions

  • Critical Care

Interventions

OTHER

No intervention

No interventions will be performed on these patients.

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Abele Donati, MD · Università Politecnica delle Marche

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02659995 on ClinicalTrials.gov