Clinical trial NCT02516358: Glycaemic Alterations in ICU
Official title: Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycaemic blood levels during ICU stay
timeFrame: 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 outcomes:
measure: Episodes of hypoglicaemia (number)
timeFrame: For the duration of ICU stay, expected average of 10 days per patient.
measure: Episodes of hyperglycaemia (number)
timeFrame: For the duration of ICU stay, expected average of 10 days per patient.
measure: Coefficient of variation of blood glucose levels
timeFrame: 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.
measure: Time in glycaemic Range (TIR)
timeFrame: 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.
measure: Days of mechanical ventilation
timeFrame: Participants will be followed for the duration of ICU stay, expected average per patient: 10 days
measure: Days of continuous renal replacement therapy
timeFrame: Participants will be followed for the duration of ICU stay, expected average per patient: 10 days
measure: Neuron Specific Enolase (NSE) blood levels and glycaemic disorders
timeFrame: NSE collection: Time point A: ICU admission. Time point NSE: 48-72 hours after ICU admission
Other outcomes:
Locations:
Study officials:
References:
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