- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00871832
Pre-admission Hyperglycemia and Its Effect on Morbidity and Mortality
June 5, 2013 updated by: Mario Castellanos, Northwell Health
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Staten Island, New York, United States, 10305
- Staten Island University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give consent.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
morbidity and mortality
Time Frame: at time of review
|
looking to see if HbA1C correlates with morbidity (i.e.
sepsis, renal failure, length of stay) or death
|
at time of review
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mario Castellanos, MD, Staten Island University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 26, 2009
First Submitted That Met QC Criteria
March 27, 2009
First Posted (Estimate)
March 30, 2009
Study Record Updates
Last Update Posted (Estimate)
June 6, 2013
Last Update Submitted That Met QC Criteria
June 5, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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