Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery

Brief Title

Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery

Official Title

Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality

Brief Summary

      Aggressive intraoperative and postoperative management of blood glucose may substantially
      decrease perioperative cardiovascular and infectious complications in diabetic and
      non-diabetic patients undergoing vascular surgery.

      The purpose of this study is to compare the tight versus traditional blood glucose control in
      diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative
      fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections,
      overall morbidity and 30-day mortality.
    

Detailed Description

      This is a randomized, prospective controlled trial in both diabetic and non diabetic patients
      undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass
      procedures and amputations, comparing tight versus standard blood glucose control regimens in
      the operating room, post anesthesia care unit and in the postoperative vascular intensive
      care unit up to 48 hours and its impact on the cardiovascular, infectious and other morbidity
      and mortality during the hospital admission and up to 30 days from surgery.

      After obtaining informed consent, the study subjects will be randomized to tight versus
      standard blood glucose control regimens. These regimens will be started in the operating room
      and continued for the first 48 hours or until their discharge, whichever is earlier. All the
      patients will be inpatients. Day surgery patients will be excluded.

      The anesthesiologist providing patient care will be given either the tight glucose control
      protocol or the standard sliding scale insulin protocol. In the tight control regimen, target
      blood glucose is 100-150 mg/dl. If 3 consecutive blood glucose (BG) level >150 mg/dL or 1 BG
      level >200 mg/dL, then the insulin infusion will be initiated in the tight control group. The
      insulin infusion rate adjustments will be made based on the blood sugar results. In post
      anesthetic care unit (PACU) and vascular intensive care unit (VICU), these protocols will be
      nurse driven. The adjustments will be made based on the current blood sugar levels as well as
      the insulin infusion rates. They are adjusted in such a way to account for the rate of change
      of blood sugars and the presence of steroid therapy in the patients. The frequency of blood
      glucose testing in this group will be every 1-hour until stable (when frequent changes in
      insulin dosage are no longer necessary, and glucose is in the range of 100 to 150 for 3
      consecutive blood sugar checks); then test every 2 hours for 3 consecutive target values and
      then every 4 hours thereafter. If there is a change in the infusion rates, then blood sugar
      checks will be done every hour and the cycle followed thereafter.

      In the standard sliding scale insulin group, blood sugars will be treated with insulin
      boluses if the blood sugars go more than 150 mg/dL and blood glucose will be monitored every
      4 hours.

      These regimens will be initiated after 2 weeks of in-service training for anesthesiologists,
      post anesthetic care unit (PACU) and vascular intensive care unit (VICU) nurses. The study
      investigators will provide this training. Insulin infusion in the tight control regimen will
      be started through pump piggyback to maintenance intravenous infusion as follows. Insulin
      infusion bags will be made by the pharmacy (100 units in a 100 ml bag). The anesthesiologists
      in the operating room and PACU, and VICU nurses will perform blood glucose monitoring, bolus
      insulin administration, and infusion initiation and rate adjustments as specified by the
      protocol. Blood glucose levels will be tested by finger stick method or arterial line drop
      sample.
    

Study Type

Interventional

Primary Outcome

Composite (Myocardial Infarction and CHF)

Secondary Outcome

 Incidence of Wound Infections

Condition

Peripheral Vascular Disease

Intervention

continuous intravenous insulin infusion

Study Arms / Comparison Groups

 CII, Continuous Insulin Infusion

Description:  Continuous intravenous insulin infusion to control glucose to <150 mg/dL in patients undergoing open peripheral vascular bypass surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

242

Start Date

March 2006

Completion Date

May 2009

Primary Completion Date

April 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Abdominal aortic surgery

          -  Supra and infrainguinal peripheral vascular bypass surgery

          -  Below knee amputations

          -  Above knee amputations

          -  Diabetics and nondiabetics

          -  American Society of Anesthesiologists (ASA) I-III

        Exclusion Criteria:

          -  Brittle diabetics

          -  ASA 1V,V

          -  Second surgery in same admission
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Balachundhar Subramaniam, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00328094

Organization ID

2005P-000299

Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center

Study Sponsor

Balachundhar Subramaniam, Principal Investigator, Beth Israel Deaconess Medical Center, Boston MA

Verification Date

April 2013