Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01916733
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2013-07-30
Brief Title:
A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Insulin Study
Sponsor:
University of Vermont Medical Center
Organization:
University of Vermont Medical Center
Study Overview
Official Title:
A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Patients After Vascular Surgery
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to examine the effect of moderate glucose blood sugar control in diabetic and non-diabetic patients undergoing leg bypass surgery LEB or open abdominal aortic aneurysm AAA repair We hypothesize that use of Fletcher Allen Health Cares current insulin infusion strategy will result in improved blood sugar control which will translate into decreased postoperative morbidity fewer complications and better long term outcomes when compared to patient outcomes at other institutions which utilize other blood sugar management strategies
Detailed Description:
We plan a concurrent matched cohort study of moderate postoperative glucose control in patients undergoing leg bypass or open AAA repair Consecutive patients undergoing elective open AAA repair or leg bypass will be enrolled over a two year period A population of de-identified patients from other institutions in the region matched for medical problems who did not receive an insulin infusion will be used as a control group
Continuous intravenous insulin protocol The insulin infusion strategy is local standard of care for control of postoperative hyperglycemia after leg bypass surgery Blood glucose monitoring is standard after open AAA surgery but the method of glucose control could range from sliding scale insulin to the use of an insulin infusion
Diabetic and non-diabetic patients will be placed on the existing Fletcher Allen Health Care standardized algorithm of continuous IV insulin immediately after surgery and continued for 72 hours The insulin infusion will be initiated if when the finger stick blood glucose is greater than or equal to 120 mgdL with a target titration goal between 80-150 mgdL The insulin infusion will be adjusted based on a defined algorithm in use at Fletcher Allen Health Care
Primary outcome measures
1 Glycemic control as measured by mean daily glucose levels and mean daily glucose excursions We will look at the patients finger-stick records and record the time spent at goal glucose levels 80 to 150 mgdL
2 Surgical site infection SSI in-hospital will be defined according to the Centers for Disease Control definition16 as an infection that occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the infection and includes one of the following
1 purulent drainage from superficial incision
2 organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
3 at least one of the following signs or symptoms of infection pain or tenderness localized swelling redness or heat and the incision is deliberately opened by the surgeon and is culture positive or not cultured Culture negative does not meet this criterion
4 Diagnosis of superficial incisional SSI by the surgeon or attending 3 Surgical site infection at 30 days
Secondary outcome measures
1 Moderate to severe hypoglycemic or hyperglycemic events as defined by moderate hypoglycemic event as 66 mgdl and severe hypoglycemic event as 50 mgdl and moderate hyperglycemic event as 250 mgdl and severe hyperglycemic event as 500 mgdl
2 Composite cardiac complications myocardial infarction congestive heart failure and clinically significant arrhythmias within 30 days of surgery
3 Hospital length of stay re-admission and total costs of the hospitalization Cost data will be obtained through Fletcher Allen Health Care administrative data At the patients 4 week follow up they will be asked if since their discharge have they had any health related visits if so what type and for anything possibly related to the surgical procedure obtain the participants permission in writing to gather that data from the other provider
Continuous intravenous insulin protocol The insulin infusion strategy is local standard of care for control of postoperative hyperglycemia after leg bypass surgery Blood glucose monitoring is standard after open AAA surgery but the method of glucose control could range from sliding scale insulin to the use of an insulin infusion
Diabetic and non-diabetic patients will be placed on the existing Fletcher Allen Health Care standardized algorithm of continuous IV insulin immediately after surgery and continued for 72 hours The insulin infusion will be initiated if when the finger stick blood glucose is greater than or equal to 120 mgdL with a target titration goal between 80-150 mgdL The insulin infusion will be adjusted based on a defined algorithm in use at Fletcher Allen Health Care
Primary outcome measures
1 Glycemic control as measured by mean daily glucose levels and mean daily glucose excursions We will look at the patients finger-stick records and record the time spent at goal glucose levels 80 to 150 mgdL
2 Surgical site infection SSI in-hospital will be defined according to the Centers for Disease Control definition16 as an infection that occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the infection and includes one of the following
1 purulent drainage from superficial incision
2 organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
3 at least one of the following signs or symptoms of infection pain or tenderness localized swelling redness or heat and the incision is deliberately opened by the surgeon and is culture positive or not cultured Culture negative does not meet this criterion
4 Diagnosis of superficial incisional SSI by the surgeon or attending 3 Surgical site infection at 30 days
Secondary outcome measures
1 Moderate to severe hypoglycemic or hyperglycemic events as defined by moderate hypoglycemic event as 66 mgdl and severe hypoglycemic event as 50 mgdl and moderate hyperglycemic event as 250 mgdl and severe hyperglycemic event as 500 mgdl
2 Composite cardiac complications myocardial infarction congestive heart failure and clinically significant arrhythmias within 30 days of surgery
3 Hospital length of stay re-admission and total costs of the hospitalization Cost data will be obtained through Fletcher Allen Health Care administrative data At the patients 4 week follow up they will be asked if since their discharge have they had any health related visits if so what type and for anything possibly related to the surgical procedure obtain the participants permission in writing to gather that data from the other provider
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UVM Medical Group | OTHER_GRANT | UVM Medical Group | None |