Hyperglycemia in a Coronary Intensive Care Unit
Primary Purpose
Diabetes Mellitus, Hyperglycemia, Blood Glucose
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Patients with acute coronary syndrome (non ST segment elevation)and myocardial infarction admitted to coronary ICU only via emergency room
Exclusion Criteria:
- Patients admitted to coronary ICU from other hospital wards
- Patients with any disease that will need drugs that may interfere with blood glucose negatively (mannitol, glucocorticoids, vasopressor agents, etc.)
Sites / Locations
- Baskent University Faculty of Medicine, Adana Medical Center
Outcomes
Primary Outcome Measures
To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU.
Secondary Outcome Measures
To search for the cases with stress hyperglycemia and inquire its relationship with disease severity and functional outcomes, such as longevity of ICU stay.
Full Information
NCT ID
NCT00984737
First Posted
September 24, 2009
Last Updated
September 24, 2009
Sponsor
Baskent University
1. Study Identification
Unique Protocol Identification Number
NCT00984737
Brief Title
Hyperglycemia in a Coronary Intensive Care Unit
Official Title
Newly Diagnosed Hyperglycemia and Stress Hyperglycemia in a Coronary Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Newly diagnosed hyperglycemia (NDH) and stress hyperglycemia (SH) during acute illness is reported as a non-physiological condition in hospitals. The investigators aim is to determine the rate of NDH and SH among cases admitted to coronary ICU with acute coronary disease and to inquire the relationship of SH with disease severity and functional outcomes such as longevity of ICU stay.
Detailed Description
Patients with acute coronary heart disease admitted to the emergency room will be recruited consecutively. Admission plasma glucose (APG) and fasting plasma glucose (FPG); the first morning after admission, measurements will be obtained and each participant will be subjected to capillary glucose measurement (CGM) every six hours within the first day.
Patients will be separated into 4 groups:
GROUP 1: Normoglycemic cases GROUP 2: Newly diagnosed hyperglycemic cases Group 2a: Unrecognized diabetes, hbA1c: >6.0% Group 2b: Stress hyperglycemia <6.0%. GROUP 3: Known diabetes Age, gender, co-morbidities on admission, adverse outcomes in hospital, duration of stay in coronary ICU, deaths, drugs, and glucose levels will be all recorded.
Throughout the hospital stay of Group 2 and Group 3, CGMs were performed and treated when necessary (target glucose<180mg/dl).
Acute Physiology and Chronic Health Evaluation II (APACHE-II); a severity of disease classification system was used for each case.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hyperglycemia, Blood Glucose, Myocardial Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Capillary glucose measurements of Group 2 and Group 3 will be performed during hospitalization and will be treated when they are over 180mg/dl.
Short acting oral anti-diabetic drugs will be given to patients who refuse insulin injection.
Primary Outcome Measure Information:
Title
To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU.
Secondary Outcome Measure Information:
Title
To search for the cases with stress hyperglycemia and inquire its relationship with disease severity and functional outcomes, such as longevity of ICU stay.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with acute coronary syndrome (non ST segment elevation)and myocardial infarction admitted to coronary ICU only via emergency room
Exclusion Criteria:
Patients admitted to coronary ICU from other hospital wards
Patients with any disease that will need drugs that may interfere with blood glucose negatively (mannitol, glucocorticoids, vasopressor agents, etc.)
Facility Information:
Facility Name
Baskent University Faculty of Medicine, Adana Medical Center
City
Adana
ZIP/Postal Code
01250
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
11889147
Citation
Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.
Results Reference
result
PubMed Identifier
10546015
Citation
Norhammar AM, Ryden L, Malmberg K. Admission plasma glucose. Independent risk factor for long-term prognosis after myocardial infarction even in nondiabetic patients. Diabetes Care. 1999 Nov;22(11):1827-31. doi: 10.2337/diacare.22.11.1827.
Results Reference
result
PubMed Identifier
11219223
Citation
McCowen KC, Malhotra A, Bistrian BR. Stress-induced hyperglycemia. Crit Care Clin. 2001 Jan;17(1):107-24. doi: 10.1016/s0749-0704(05)70154-8.
Results Reference
result
PubMed Identifier
10711923
Citation
Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.
Results Reference
result
PubMed Identifier
20674059
Citation
Ertorer ME, Haydardedeoglu FE, Erol T, Anaforoglu I, Binici S, Tutuncu NB, Sezgin A, Demirag NG. Newly diagnosed hyperglycemia and stress hyperglycemia in a coronary intensive care unit. Diabetes Res Clin Pract. 2010 Oct;90(1):8-14. doi: 10.1016/j.diabres.2010.05.023. Epub 2010 Jul 31.
Results Reference
derived
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Hyperglycemia in a Coronary Intensive Care Unit
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