An observational study in Glycemic Control, Surgical Site Infections and Cardiac Complications, sponsored by University of Vermont Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-10-25.
Sponsored by University of Vermont Medical Center · Observational
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 Care's 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.
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 mg/dL, with a target titration goal between 80-150 mg/dL. The insulin infusion will be adjusted based on a defined algorithm in use at Fletcher Allen Health Care.
Primary outcome measures:
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:
Secondary outcome measures:
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 89 is below the median of 240 across 133 observational studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →University of Vermont Medical Center is the lead sponsor of 43 studies on the registry; 19 are open to participants now.
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LEB and open AAA patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Lower Extremity Bypass (LEB) and open AAA patients will be placed on standard Fletcher Allen Health Care insulin protocol post op
Drug: standard insulin protocol post-op (continuous IV insulin)
patients from the Vascular Study Group of New England centers without a defined program for glucose control after lower extremity bypass and open AAA repair will be used
concurrent, matched cohort study of moderate postoperative glucose control in patients undergoing LEB or open AAA repair.Propensity score matching is a statistical method used to reduce the confounding effects of covariates in an observational (non-randomized) study. In practice we will select a number of variables that impact wound infection; age, gender, diabetic and non-diabetic populations, renal insufficiency (defined at creatinine ≥1.8) and indication for surgery (claudication or critical limb ischemia with rest pain or tissue loss or open AAA repair); and chose a group of patients in the Vascular Study Group matched for these variables who have not been treated with an insulin infusion). Consecutive patients undergoing elective open AAA repair or infrainguinal LEB for claudication and critical limb ischemia will be invited to enroll in the study.
glycemic control
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 mg/dL.
Time frame: during intial hospital stay which is an average of 3 to 7 days
surgical site infection
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: * purulent drainage from superficial incision * organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision * 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. * Diagnosis of superficial incisional SSI by the surgeon or attending.
Time frame: 30 days
hypo and hyper glycemic events
. Moderate to severe hypoglycemic or hyperglycemic events as defined by moderate hypoglycemic event as \<66 mg/dl and severe hypoglycemic event as \<50 mg/dl and moderate hyperglycemic event as \>250 mg/dl and severe hyperglycemic event as \>500 mg/dl.
Time frame: during initial hospital stay avg 3 to 7 days
cardiac complications
Composite cardiac complications: myocardial infarction, congestive heart failure and clinically significant arrhythmias within 30 days of surgery
Time frame: 30 days
length of stay
Hospital length of stay
Time frame: initial hospitalization avg 3 to 7 days
re-admission
At the patient's 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 surgical procedure; will obtain participant's permission (in writing) to gather data from other provider.
Time frame: at 4 week follow-up
Costs
Cost data will be obtained through Fletcher Allen administrative data.
Time frame: 30 days
The record gives a start of Jan 2013, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Vermont Medical Center