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Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

Associated Factors in Perioperative Hypoglycemia in Patients With Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00826007
Enrollment
587
Registered
2009-01-21
Start date
2009-01-31
Completion date
2011-07-31
Last updated
2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypoglycemia

Keywords

perioperative hypoglycemia diabetes surgery, surgery

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.

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.

Interventions

None listed

Sponsors

Oakland University
CollaboratorOTHER
Corewell Health East
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hypoglycemia Incidenceperioperative periodBlood glucose values \<70 mg/dl

Countries

United States

Participant flow

Recruitment details

Retrospective review of patients who underwent surgical procedures at our institution from 2003-2009

Pre-assignment details

Retrospective

Participants by arm

ArmCount
Low Normal Group
Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
308
Hyperglycemia-treated Group
Patients with diabetes who had preoperative blood glucose values \>249 mg/dl and were subsequently treated with insulin
279
Total587

Baseline characteristics

CharacteristicHyperglycemia-treated GroupTotalLow Normal Group
Age Continuous56.34 years
STANDARD_DEVIATION 14.18
58.96 years
STANDARD_DEVIATION 14.57
61.34 years
STANDARD_DEVIATION 14.93
Beta-blocker medication in regimen
Documented Beta blocker use
107 participants255 participants148 participants
Beta-blocker medication in regimen
No documented beta blocker use
172 participants332 participants160 participants
Diabetes type
Type 1 diabetes
47 participants84 participants37 participants
Diabetes type
Type 2 diabetes
175 participants392 participants217 participants
Diabetes type
type not documented
57 participants111 participants54 participants
Insulin regimen prior to preop arrival
Insulin use
240 participants506 participants266 participants
Insulin regimen prior to preop arrival
No documented insulin use
39 participants81 participants42 participants
Region of Enrollment
United States
279 participants587 participants308 participants
Renal disease
Renal disease documented
54 participants139 participants85 participants
Renal disease
Renal disease not documented
225 participants448 participants223 participants
Sex: Female, Male
Female
137 Participants279 Participants142 Participants
Sex: Female, Male
Male
142 Participants308 Participants166 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Hypoglycemia Incidence

Blood glucose values \<70 mg/dl

Time frame: perioperative period

ArmMeasureValue (NUMBER)
Low Normal GroupHypoglycemia Incidence53 participants
Hyperglycemia-treated GroupHypoglycemia Incidence10 participants
p-value: <0.00195% CI: [0.09, 0.18]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026