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Glycaemic Alterations in ICU

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ClinicalTrials.gov Identifier: NCT02516358
Recruitment Status : Unknown
Verified August 2015 by Francesca Di Muzio, Catholic University of the Sacred Heart.
Recruitment status was:  Not yet recruiting
First Posted : August 5, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Francesca Di Muzio, 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.

Condition or disease
Diabetes Mellitus

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study
Study Start Date : September 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : September 2016



Primary Outcome Measures :
  1. Change in glycaemic blood levels during ICU stay [ Time Frame: 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 :
  1. Episodes of hypoglicaemia (number) [ Time Frame: For the duration of ICU stay, expected average of 10 days per patient. ]
  2. Episodes of hyperglycaemia (number) [ Time Frame: For the duration of ICU stay, expected average of 10 days per patient. ]
  3. Coefficient of variation of blood glucose levels [ Time Frame: 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

  4. Time in glycaemic Range (TIR) [ Time Frame: 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

  5. Days of mechanical ventilation [ Time Frame: Participants will be followed for the duration of ICU stay, expected average per patient: 10 days ]
  6. Days of continuous renal replacement therapy [ Time Frame: Participants will be followed for the duration of ICU stay, expected average per patient: 10 days ]
  7. Neuron Specific Enolase (NSE) blood levels and glycaemic disorders [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516358


Contacts
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Contact: Francesca Di Muzio 0467556315; 00393470333656 francescadimuzio@gmail.com

Sponsors and Collaborators
Catholic University of the Sacred Heart
Publications:

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Responsible Party: Francesca Di Muzio, Medical Doctor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02516358    
Other Study ID Numbers: Gly 1
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015