A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Insulin Study

NCT01916733 | Completed

• 2 other identifiers: M12-172UVM Medical Group
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Glycemic Control; Surgical Site Infections; Cardiac Complications; Length of Stay; Cost

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Drug: standard insulin protocol post-op (continuous IV insulin)

control

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

Interventions

standard insulin protocol post-op (continuous IV insulin) DRUG

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.

Lower Extremity Bypass & open AAA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

LEB and open AAA patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 6, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

US (1)