NCT04679025

Brief Summary

Patients with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. Previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. Using a framework for perioperative glycemic management, we sought to measure quality gaps in perioperative glycemic care. This cross-sectional study used administrative data to measure the proportion of surgical patients with and without known diabetes who underwent preoperative hemoglobin A1c measurement, postoperative point-of-care testing for glucose (POCT), had hyperglycemia, and received basal bolus insulin regimens for treatment. We performed an exploratory analysis comparing length of stay (LOS) in patients with and without diabetes who had and did not have postoperative hyperglycemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 11, 2020

Last Update Submit

December 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of point of care blood glucose measurements in 24-hours after surgery

    24-hours post surgery

  • Proportion of patients who have hyperglycemia

    blood or capillary glucose \> 10 mmol/L

    24-hours after surgery

Secondary Outcomes (3)

  • Proportion of patients who have moderate hyperglycemia

    24-hours after surgery

  • Proportion of patients who have severe hyperglycemia

    24-hours after surgery

  • Hospital Length of stay

    Until study completion (up to one year from surgical procedure)

Study Arms (4)

Diabetes with postoperative hyperglycemia

Patients with known diabetes (Discharge Abstract Database or hemoglobin A1c \> 6.5%) who had postoperative hyperglycemia (point of care test \> 10.0 mmol/L).

Other: Exposure - postoperative hyperglycemia

Diabetes without postoperative hyperglycemia

Patients with known diabetes (Discharge Abstract Database or hemoglobin A1c \> 6.5%) who did not have postoperative hyperglycemia (point of care test \> 10.0 mmol/L).

No diabetes with postoperative hyperglycemia

Patients without known diabetes (Discharge Abstract Database or hemoglobin A1c \> 6.5%) who had postoperative hyperglycemia (point of care test \> 10.0 mmol/L).

Other: Exposure - postoperative hyperglycemia

No diabetes and no postoperative hyperglycemia

Patients without known diabetes (Discharge Abstract Database or hemoglobin A1c \> 6.5%) who did not have postoperative hyperglycemia (point of care test \> 10.0 mmol/L).

Interventions

Postoperative hyperglycemia (blood or capillary glucose \> 10.0 mmol/L) within 72 hours of a surgical procedure

Diabetes with postoperative hyperglycemiaNo diabetes with postoperative hyperglycemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing a surgical procedure at the Foothills Medical Centre who were admitted for at least 24-hours.

You may qualify if:

  • Underwent inpatient surgical procedure at the Foothills Medical Centre between Apr 1 2019 and March 31 2020
  • Stayed in hospital for more than 24-hours after surgery

You may not qualify if:

  • Younger than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 4T9, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 22, 2020

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

Data is available from the study principal investigator upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Present for five years after study completion (March 31 2020).
Access Criteria
Email shannon.ruzycki@ucalgary.ca

Locations