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Glycaemic Alterations in ICU

Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02516358
Enrollment
100
Registered
2015-08-05
Start date
2015-09-30
Completion date
2016-09-30
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

None listed

Sponsors

Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in glycaemic blood levels during ICU stayGlycaemic 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

MeasureTime frameDescription
Episodes of hyperglycaemia (number)For the duration of ICU stay, expected average of 10 days per patient.
Coefficient of variation of blood glucose levelsTime 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
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.
Days of continuous renal replacement therapyParticipants will be followed for the duration of ICU stay, expected average per patient: 10 days
Neuron Specific Enolase (NSE) blood levels and glycaemic disordersNSE collection: Time point A: ICU admission. Time point NSE: 48-72 hours after ICU admissionTo detect a correlation between NSE levels and glycaemic alterations in both diabetic and non diabetic patients.
Days of mechanical ventilationParticipants will be followed for the duration of ICU stay, expected average per patient: 10 days

Contacts

Primary ContactFrancesca Di Muzio
francescadimuzio@gmail.com0467556315; 00393470333656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026