Hyperglycemia in a Coronary Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00984737
First received: September 24, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Hyperglycemia
Blood Glucose
Myocardial Ischemia
Drug: Insulin

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Newly Diagnosed Hyperglycemia and Stress Hyperglycemia in a Coronary Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Baskent University:

Primary Outcome Measures:
  • To determine the prevalence of newly diagnosed hyperglycemia in coronary ICU. [ Designated as safety issue: No ]

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. [ Designated as safety issue: Yes ]

Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00984737

Locations
Turkey
Baskent University Faculty of Medicine, Adana Medical Center
Adana, Turkey, 01250
Sponsors and Collaborators
Baskent University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00984737     History of Changes
Other Study ID Numbers: KA07/101
Study First Received: September 24, 2009
Last Updated: September 24, 2009
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Myocardial Ischemia
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014