The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calgary

About this trial

The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are:

* What is the prevalence of hyperglycemia in surgical patients with prediabetes? * What is the relative risk of postoperative complications associated with hyperglycemia?

To answer these questions, surgical patients with prediabetes will undergo universal glucose measurement in the perioperative period. Glucose data will be analyzed in conjunction with electronic health record (EHR) data describing patient outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hemoglobin A1c measurement between 6 and 6.4%

Scheduled for non-cardiac surgery

Disqualifiers

Age>18

Pregnancy

Any formal diabetes diagnosis

Current use of medications that influence blood glucose regardless of the indication

Trial population

Surgical in-patients at the Foothills Medical Centre.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

750 Participants
are grouped into 1 trial group
Group A: Surgical Patients with Prediabetes

Trial outcomes

Primary outcomes

1

Prevalence of perioperative hyperglycemia

Prediabetes will be defined as described in Section 4.2 using Diabetes Canada definitions. The perioperative period will include the day of surgery and the early postoperative period. The day of surgery includes surgical admitting, intraoperative, and recovery room on postoperative day (POD) 0, which is the day that surgery was completed until 23:59. The early postoperative period will be defined as the first 3 full postoperative days, in keeping with studies that have demonstrated that hyperglycemia is most common in the first 72 hours after surgery and that early hyperglycemia is associated with greater 30-day postoperative mortality. Hyperglycemia will be defined using Diabetes Canada reference ranges as any glucose value \>10.0 mmol/L by any form of glucose measurement.

Time frame
Up to the first 3 postoperative days or discharge, whichever comes first.

Secondary outcomes

1

Post-operative complications

Postoperative complications are defined in accordance with the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), a standardized list of preventable complications developed by surgeons and used internationally to describe hospital-level quality of surgical care. These include the following adverse events within 30 days of surgery: SSIs (superficial, deep incisional, organ/space, using the Centres for Disease Control definitions), wound dehiscence, pneumonia, unplanned intubation, pulmonary embolism, ventilator use \>48 hours, acute renal failure, urinary tract infection, stroke, cardiac arrest, myocardial infarction, transfusion complications, deep vein thrombosis, sepsis, septic shock, Clostridium difficile infection, death, readmissions, and unplanned reoperations.

Time frame
Within 30 days of surgery.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: