Pre-admission Hyperglycemia and Its Effect on Morbidity and Mortality

Hyperglycemia Clinical Trial

Official title:

To Evaluate if Pre-admission Hyperglycemia Measured by Glycosylated Hemoglobin Level Affects the Morbidity and Mortality of Patients in a Mixed Medical and Surgical Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871832
• Other study ID #: 07-020
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: June 5, 2013
• Start date: May 2007
• Est. completion date: March 2010

Study information

• Verified date: June 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

It is currently standard of care in many Medical and Surgical ICU's to institute a nurse driven insulin protocol in maintaining tight glucose control in the critical patient. Many articles have been written to address this topic. However, there is no current data regarding the use of glycohemoglobin as a marker of risk of morbidity and mortality. In our study we would like to determine whether or not the HbA1C could be used as a marker of morbidity and mortality. The HbA1C is a simple blood test that may be added on to any CBC collection tube; a blood sample that critical patients have drawn up to several times a day. The investigators would analyze this information in respect to the rest of the clinical data collected regarding the patient's illness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperglycemia

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity and mortality	looking to see if HbA1C correlates with morbidity (i.e. sepsis, renal failure, length of stay) or death	at time of review	No