Glycaemic Alterations in ICU

• Conditions: Diabetes Mellitus

• Registration Number: NCT02516358
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study First Submitted: 2015-05-20
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-05
• Last Update Submitted: 2015-08-31
• Study Start: 2015-09
• Last Update Posted: 2015-09-01
• Primary Completion: 2016-02
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Coefficient of variation of blood glucose levels	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.	Coefficient of Variation, calculated as a percentage
Episodes of hyperglycaemia (number)	For the duration of ICU stay, expected average of 10 days per patient.
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	NSE collection: Time point A: ICU admission. Time point NSE: 48-72 hours after ICU admission	To detect a correlation between NSE levels and glycaemic alterations in both diabetic and non diabetic patients.
Days of mechanical ventilation	Participants will be followed for the duration of ICU stay, expected average per patient: 10 days
Time in glycaemic Range (TIR)	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.	Evaluated in hours TIR/ total hours in ICU; calculated as a percentage
Episodes of hypoglicaemia (number)	For the duration of ICU stay, expected average of 10 days per patient.