ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Diabetes in the Perioperative Period

This study is currently recruiting participants.
Verified by Emory University, October 2008

Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00738114
  Purpose

High blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality. High blood glucose has also been associated with poor outcome in non-critically ill patients admitted to general surgical and medical wards; however, intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2008 provided very little information on the prevalence and outcome of high blood glucose during the perioperative period (before and after surgery) in non-critically ill patients. Therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery. We will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at Emory University Hospital as inpatient.


Condition
Hyperglycemia
Diabetes

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Retrospective
Official Title:   Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome

Further study details as provided by Emory University:

Primary Outcome Measures:
  • assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery. [ Time Frame: 01/01/07 - 06/30/2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine the scope of clinical inertia in patients with diabetes and untreated hyperglycemia in patients undergoing non-cardiac surgery [ Time Frame: 01/01/07 - 06/30/2007 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   1500
Study Start Date:   August 2008
Estimated Study Completion Date:   August 2009
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
group without hyperglycemia (fasting blood glucose below 126mg/dl) approximately 1000 patients
2
group with hyperglycemia (fasting blood glucose above 125 mg/dl) or history of diabetes approximately 500 patients

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007


Criteria

Inclusion Criteria:

  • patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria:

  • outpatient procedures, cardiac surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738114

Contacts
Contact: Guillermo Umpierrez, MD     404-778-1665     geumpie@emory.edu    
Contact: Anna Frisch, MD, PhD     404-219-7814     afrisch@emory.edu    

Locations
United States, Georgia
Emory Universiy Hospital     Recruiting
      Atlanta, Georgia, United States, 30322
      Contact: Anna Firsch, MD, PhD     404-219-7814     afrisch@emory.edu    
      Contact: Natasha Khazai, MD     404-778-1687     nkhazai@emory.edu    

Sponsors and Collaborators
Emory University

Investigators
Principal Investigator:     Guillermo Umpierrez, MD     Emory University    
  More Information


Responsible Party:   Emory University School of Medicine ( Guillermo Umpierrez, MD Professor of Medicine )
Study ID Numbers:   11938
First Received:   August 19, 2008
Last Updated:   October 7, 2008
ClinicalTrials.gov Identifier:   NCT00738114
Health Authority:   United States: Institutional Review Board

Keywords provided by Emory University:
non-cardiac  
surgery  
mortality  
morbidity
perioperative
period

Study placed in the following topic categories:
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers