Pre-admission Hyperglycemia and Its Effect on Morbidity and Mortality

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Mario Castellanos, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00871832
First received: March 26, 2009
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


Condition
Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • morbidity and mortality [ Time Frame: at time of review ] [ Designated as safety issue: No ]
    looking to see if HbA1C correlates with morbidity (i.e. sepsis, renal failure, length of stay) or death


Enrollment: 200
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871832

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
Investigators
Principal Investigator: Mario Castellanos, MD Staten Island University Hospital
  More Information

No publications provided

Responsible Party: Mario Castellanos, Clinical Director of Research, Dept. of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00871832     History of Changes
Other Study ID Numbers: 07-020
Study First Received: March 26, 2009
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
hyperglycemia
HgA1c
mortality

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014