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Completed

NCT Number: NCT00826007

Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hypoglycemia Incidence

    Time frame: perioperative period

    Blood glucose values <70 mg/dl

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • Oakland University

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2009
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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