Glycaemic Alterations in ICU

Diabetes Mellitus Clinical Trial

Official title:

Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02516358
• Other study ID #: Gly 1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 20, 2015
• Last updated: August 31, 2015
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Catholic University of the Sacred Heart
• Contact: Francesca Di Muzio
• Phone: 0467556315; 00393470333656
• Email: francescadimuzio[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

References & Publications (11)

Cely CM, Arora P, Quartin AA, Kett DH, Schein RM. Relationship of baseline glucose homeostasis to hyperglycemia during medical critical illness. Chest. 2004 Sep;126(3):879-87. — View Citation

Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5. Review. — View Citation

Egi M, Bellomo R, Stachowski E, French CJ, Hart GK, Hegarty C, Bailey M. Blood glucose concentration and outcome of critical illness: the impact of diabetes. Crit Care Med. 2008 Aug;36(8):2249-55. doi: 10.1097/CCM.0b013e318181039a. — View Citation

Kalfon P, Le Manach Y, Ichai C, Bréchot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients. Crit Care. 2015 Apr 8;19:153. doi: 10.1186/s13054-015-0851-7. — View Citation

Kochanek PM, Berger RP, Bayir H, Wagner AK, Jenkins LW, Clark RS. Biomarkers of primary and evolving damage in traumatic and ischemic brain injury: diagnosis, prognosis, probing mechanisms, and therapeutic decision making. Curr Opin Crit Care. 2008 Apr;14(2):135-41. doi: 10.1097/MCC.0b013e3282f57564. Review. — View Citation

Krinsley JS, Egi M, Kiss A, Devendra AN, Schuetz P, Maurer PM, Schultz MJ, van Hooijdonk RT, Kiyoshi M, Mackenzie IM, Annane D, Stow P, Nasraway SA, Holewinski S, Holzinger U, Preiser JC, Vincent JL, Bellomo R. Diabetic status and the relation of the three domains of glycemic control to mortality in critically ill patients: an international multicenter cohort study. Crit Care. 2013 Mar 1;17(2):R37. doi: 10.1186/cc12547. — View Citation

Krinsley JS, Meyfroidt G, van den Berghe G, Egi M, Bellomo R. The impact of premorbid diabetic status on the relationship between the three domains of glycemic control and mortality in critically ill patients. Curr Opin Clin Nutr Metab Care. 2012 Mar;15(2):151-60. doi: 10.1097/MCO.0b013e32834f0009. Review. — View Citation

Krinsley JS, Preiser JC. Time in blood glucose range 70 to 140 mg/dl >80% is strongly associated with increased survival in non-diabetic critically ill adults. Crit Care. 2015 Apr 20;19:179. doi: 10.1186/s13054-015-0908-7. — View Citation

NICE-SUGAR Study Investigators, Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24. — View Citation

Plummer MP, Bellomo R, Cousins CE, Annink CE, Sundararajan K, Reddi BA, Raj JP, Chapman MJ, Horowitz M, Deane AM. Dysglycaemia in the critically ill and the interaction of chronic and acute glycaemia with mortality. Intensive Care Med. 2014 Jul;40(7):973-80. doi: 10.1007/s00134-014-3287-7. Epub 2014 Apr 24. — View Citation

Sulter G, Elting JW, De Keyser J. Increased serum neuron specific enolase concentrations in patients with hyperglycemic cortical ischemic stroke. Neurosci Lett. 1998 Aug 28;253(1):71-3. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Episodes of hypoglicaemia (number)		For the duration of ICU stay, expected average of 10 days per patient.	No
Secondary	Episodes of hyperglycaemia (number)		For the duration of ICU stay, expected average of 10 days per patient.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Days of mechanical ventilation		Participants will be followed for the duration of ICU stay, expected average per patient: 10 days	No
Secondary	Days of continuous renal replacement therapy		Participants will be followed for the duration of ICU stay, expected average per patient: 10 days	No
Secondary	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	No