Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00826007

Recruitment Status : Completed

First Posted : January 21, 2009

Results First Posted : May 27, 2013

Last Update Posted : May 27, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Oakland University

Information provided by (Responsible Party):

Tamra Dukatz, William Beaumont Hospitals

Study Description

Brief Summary:

The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment.

Condition or disease
Diabetes Hypoglycemia

Detailed Description:

With evidence linking surgical morbidity to hyperglycemia (high blood sugar), attention to glucose control is warranted during surgery as well as in the postoperative period. Consequently, measures to prevent and treat hyperglycemia - coupled with fasting status - places patients at considerable risk for perioperative hypoglycemia (low blood sugar). Outpatient patient studies support that profound hypoglycemia can be deleterious and even fatal to patients.

This descriptive study will utilize retrospective chart review to examine factors associated with hypoglycemia. Charts from 700 subjects who experienced blood glucose values less than 70 mg/dl primarily in the preoperative and postanesthesia care units at William Beaumont Hospital-Royal Oak will be reviewed. Another 1600 charts will be screened for subsequent intraoperative hypoglycemia: 800 that had low normal preoperative glucose values and 800 that had high preoperative values (with likelihood of insulin therapy).

Numerous factors believed to be associated with perioperative hypoglycemia will be analyzed including type and duration of diabetes, usual diabetes treatment regimen and alterations on day of surgery, self-reported usual fasting blood sugar range, duration of fasting, type of surgery and anesthesia, co-morbidities, and medications associated with hypoglycemia.

Determining factors associated with perioperative hypoglycemia will improve prediction of which patients are at highest risk for hypoglycemia, enabling healthcare providers to institute more conservative insulin therapy when indicated, initiate early maintenance intravenous dextrose, and/ or perform more frequent glucose testing. Identifying associated factors will improve hypoglycemic predictions and interventions which should lead to safer, more effective care for patients with diabetes.

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	587 participants
Time Perspective:	Retrospective
Official Title:	Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes
Study Start Date :	January 2009
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Hypoglycemia Incidence [ Time Frame: perioperative period ]
Blood glucose values <70 mg/dl

Biospecimen Retention: None Retained

non applicable

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Surgical patients

Criteria

Inclusion Criteria:

Patients who underwent surgery at William Beaumont Hospital in Royal Oak, Michigan between January 1, 2003, and January 1, 2009.
Point of care testing identified a blood sugar value less than 69 mg/dl at any time in the perioperative area; or a value between 70-89 mg/dl in the preoperative area; or a glucose value greater than 250 mg/dl in the preoperative area.

Exclusion Criteria:

Obstetric patients.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826007

Locations

Layout table for location information

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Oakland University

Investigators

Layout table for investigator information

Principal Investigator:	Solomon I Rosenblatt, MD	Michigan Endocrine Consultants
Principal Investigator:	Tamra Dukatz, CRNA	Beaumont Health System

More Information

Layout table for additonal information

Responsible Party:	Tamra Dukatz, CRNA, Anesthesia Department, William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00826007
Other Study ID Numbers:	2008-281
First Posted:	January 21, 2009 Key Record Dates
Results First Posted:	May 27, 2013
Last Update Posted:	May 27, 2013
Last Verified:	March 2013

Keywords provided by Tamra Dukatz, William Beaumont Hospitals:


perioperative hypoglycemia diabetes surgery surgery

Additional relevant MeSH terms:

Layout table for MeSH terms

Diabetes Mellitus Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

To Top