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

NCT02659995 | Unknown

• 1 other identifier: GLINF001
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Care

Keywords

glycemic variability; infection

Outcome Measures

Primary Outcomes (1)

• Relationship between Glycemic Lability Index and arise of new infections.

  Evaluation of the discriminatory power of Glycemic Lability Index (GLI) on infections development with AUC (ROC curve).

  Study frame: 1 year

Secondary Outcomes (1)

• Mortality

  Study frame: 1 year

Interventions

No intervention OTHER

No interventions will be performed on these patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients consecutively admitted in the participating ICUs.

You may qualify if:

• All the patients admitted in ICU

You may not qualify if:

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

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

University ICU, AOU Ospedali Riuniti Ancona

Ancona, The Marches, 60126, Italy

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

• Abele Donati, MD

  Università Politecnica delle Marche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abele Donati, MD

CONTACT

+390715964603; a.donati@univpm.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 21, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

IT (1)