Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589466
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Preoperative Optimization of Diabetic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Review of Preoperative Optimization of Diabetic Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic patients as part of preoperative evaluation should have glycated hemoglobin HbA1C measured HbA1C provides information on longterm glucose control There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events including infections myocardial infarction and mortality It is unclear whether chronic glycemia as reflected in raised HbA1C level is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management Conversely in a retrospective analysis of 431480 surgeries perioperative glucose was predictive of increased 30-day mortality but that HbA1C was a less useful predictor of this measure In our experience of at the University of Alberta Preadmission Clinic there is significant variability with respect to whether diabetic patients have a valid HbA1C measurement ie within 3 months of surgery If a valid measurement is present there is also considerable variability with respect to diabetes control
Detailed Description:
Purpose The purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid HbA1C Hypothesis A valid measured within 3 months of surgery HbA1C measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal
Objectives
Perform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following
Primary outcomes
1 Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients
2 Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
3 Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
Secondary outcomes
1 Determine association between HbA1C and post-operative length of stay
2 Determine association between HbA1C and in hospital mortality Design This study will be a population-based retrospective observational cohort study Setting Alberta Hospitals Participants Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes Normally distributed continuous data will be reported as means with standard deviations SD Non-normally distributed continuous data will be reported as medians with interquartile ranges IQR Categorical variables will be compared using Chi-square test for independence
Objectives
Perform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following
Primary outcomes
1 Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients
2 Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
3 Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
Secondary outcomes
1 Determine association between HbA1C and post-operative length of stay
2 Determine association between HbA1C and in hospital mortality Design This study will be a population-based retrospective observational cohort study Setting Alberta Hospitals Participants Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes Normally distributed continuous data will be reported as means with standard deviations SD Non-normally distributed continuous data will be reported as medians with interquartile ranges IQR Categorical variables will be compared using Chi-square test for independence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None