Glycaemic Alterations in ICU

Study Overview
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Brief Summary
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To quantify the local prevalence of diabetes mellitus in critically ill patients. To understand whether a correlation does exist between premorbid glycaemic control and glycaemic status in ICU. A subgroup analysis will be conducted to investigate whether a relationship does exist between Neuron Specific Enolase levels and glycaemic disorders.

Detailed Description
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The aim of this study is to determine the local prevalence of critical illness-associated hyperglycaemia (CIAH) and recognised and unrecognised diabetes, as well as to evaluate how premorbid glycaemia impacts the relationship between three glycaemic domains and mortality. The investigators will calculate the Time In Range (TIR, 70-180 mg/dl) and evaluate distribution of percentage time in range for non-diabetics and diabetics patients, in order to understand the association between TIR and survival in both groups of patients (patients with diabetes and patients without diabetes). In view of the potential adverse effects of hyperglycaemia, hypoglycaemia and glycaemic variability on the brain, the investigators will dose Neuron Specific Enolase in critically ill patients. The aim is to define if a biochemical correlation does exist between critically ill dysglycaemia and NSE plasma concentration.

Official Title
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Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study

Conditions
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Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patients expected ICU length of stay > 48 hours Exclusion Criteria: age <18 years ICU length of stay <48 hours diabetic ketoacidosis hyperosmolar nonketonic hyperglycaemia syndrome pregnancy hypoglycaemic coma acute or acute on chronic liver failure, liver transplantation or end-stage liver disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycaemic blood levels during ICU stay |  | Glycaemic values expressed as mean glycaemia will be collected at the baseline and every 8 hours for the duration of ICU stay, expected average of 10 days per patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of hypoglicaemia (number) |  | For the duration of ICU stay, expected average of 10 days per patient. | 
| Episodes of hyperglycaemia (number) |  | For the duration of ICU stay, expected average of 10 days per patient. | 
| Coefficient of variation of blood glucose levels | Coefficient of Variation, calculated as a percentage | Time point A:24 hours. Time point B: 48 hours after ICU admission. Time point C: for the duration of ICU stay, an expected average of 10 days per patient. | 
| Time in glycaemic Range (TIR) | Evaluated in hours TIR/ total hours in ICU; calculated as a percentage | Time point A:24 hours. Time point B: 48 hours after ICU admission. Time point C: for the duration of ICU stay, an expected average of 10 days per patient. | 
| Days of mechanical ventilation |  | Participants will be followed for the duration of ICU stay, expected average per patient: 10 days | 
| Days of continuous renal replacement therapy |  | Participants will be followed for the duration of ICU stay, expected average per patient: 10 days | 
| Neuron Specific Enolase (NSE) blood levels and glycaemic disorders | To detect a correlation between NSE levels and glycaemic alterations in both diabetic and non diabetic patients. | NSE collection: Time point A: ICU admission. Time point NSE: 48-72 hours after ICU admission |