A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Patients After Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- glycemic control
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients, all patients on the vascular service undergoing elective open AAA repair or infrainguinal LEB for claudication or critical limb ischemia will be approached and given the choice to participate in or to decline the study. Diabetic and non-diabetic.
排除标准
- •Patients with purely acute limb ischemia will be excluded. Emergency operations including ruptured AAA repairs will be excluded. Also patients on a preoperative insulin infusion will be excluded.
研究组 & 干预措施
Lower Extremity Bypass & open AAA
Lower Extremity Bypass (LEB) and open AAA patients will be placed on standard Fletcher Allen Health Care insulin protocol post op
干预措施: standard insulin protocol post-op (continuous IV insulin) (Drug)
结局指标
主要结局
glycemic control
时间窗: during intial hospital stay which is an average of 3 to 7 days
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.
surgical site infection
时间窗: 30 days
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.
次要结局
- hypo and hyper glycemic events(during initial hospital stay avg 3 to 7 days)
- cardiac complications(30 days)
- length of stay(initial hospitalization avg 3 to 7 days)
- re-admission(at 4 week follow-up)
- Costs(30 days)
研究者
Daniel Bertges, MD
MD
University of Vermont Medical Center