Hyperglycemia in a Coronary Intensive Care Unit

Diabetes Mellitus Clinical Trial

Official title:

Newly Diagnosed Hyperglycemia and Stress Hyperglycemia in a Coronary Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984737
• Other study ID #: KA07/101
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: September 24, 2009
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: September 2009
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.)

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Glucose
• Coronary Artery Disease
• Diabetes Mellitus
• Hyperglycemia
• Myocardial Ischemia

Intervention

Drug:
• Insulin
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.

Locations

Country	Name	City	State
Turkey	Baskent University Faculty of Medicine, Adana Medical Center	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View Citation

McCowen KC, Malhotra A, Bistrian BR. Stress-induced hyperglycemia. Crit Care Clin. 2001 Jan;17(1):107-24. Review. — View Citation

Norhammar AM, Rydén 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU.			No
Secondary	To search for the cases with stress hyperglycemia and inquire its relationship with disease severity and functional outcomes, such as longevity of ICU stay.			Yes