Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

Diabetes Clinical Trial

Official title:

Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826007
• Other study ID #: 2008-281
• Status: Completed
• Phase: N/A
• First received: January 19, 2009
• Last updated: March 26, 2013
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes
• Hypoglycemia

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Oakland University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia Incidence	Blood glucose values <70 mg/dl	perioperative period	Yes