Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

This study has been completed.
Sponsor:
Collaborator:
Oakland University
Information provided by (Responsible Party):
Tamra Dukatz, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00826007
First received: January 19, 2009
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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
Diabetes
Hypoglycemia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Hypoglycemia Incidence [ Time Frame: perioperative period ] [ Designated as safety issue: Yes ]
    Blood glucose values <70 mg/dl


Biospecimen Retention:   None Retained

non applicable


Enrollment: 587
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826007

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Oakland University
Investigators
Principal Investigator: Solomon I Rosenblatt, MD Michigan Endocrine Consultants
Principal Investigator: Tamra Dukatz, CRNA Beaumont Health System
  More Information

No publications provided

Responsible Party: Tamra Dukatz, CRNA, Anesthesia Department, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00826007     History of Changes
Other Study ID Numbers: 2008-281
Study First Received: January 19, 2009
Results First Received: March 26, 2013
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
perioperative hypoglycemia diabetes surgery
surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014