Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery

• ClinicalTrials.gov Identifier: NCT00328094
• Recruitment Status: Terminated
• First Posted: May 19, 2006
• Results First Posted: April 9, 2013
• Last Update Posted: April 17, 2013
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Vascular Disease; Abdominal Aortic Aneurysm	Drug: continuous intravenous insulin infusion	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality
• Study Start Date: March 2006
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: CII, Continuous Insulin Infusion; Continuous intravenous insulin infusion to control glucose to <150 mg/dL in patients undergoing open peripheral vascular bypass surgery	Drug: continuous intravenous insulin infusion; Tight glucose control versus standard of care; Other Names: CII-continuous insulin infusion; II-Intermittent insulin boluses
Active Comparator: IIB, Intermittent insulin boluses; Intermittent intravenous insulin insulin boluses to a blood glucose target of <150mg/dL in patients undergoing peripheral vascular bypass surgery	Drug: continuous intravenous insulin infusion; Tight glucose control versus standard of care; Other Names: CII-continuous insulin infusion; II-Intermittent insulin boluses

Outcome Measures

Primary Outcome Measures :

1. Composite (Myocardial Infarction and CHF) [ Time Frame: hospital length of stay ]

Secondary Outcome Measures :

1. Incidence of Wound Infections [ Time Frame: postoperative ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

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

More Information

Publications:

Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2.

van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Zimmerman CR, Mlynarek ME, Jordan JA, Rajda CA, Horst HM. An insulin infusion protocol in critically ill cardiothoracic surgery patients. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1123-9. Epub 2004 May 18.

Kersten JR, Warltier DC, Pagel PS. Aggressive control of intraoperative blood glucose concentration: a shifting paradigm? Anesthesiology. 2005 Oct;103(4):677-8.

• Responsible Party: Balachundhar Subramaniam, Staff Anesthesiologist, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00328094
• Other Study ID Numbers: 2005P-000299
• First Posted: May 19, 2006
• Results First Posted: April 9, 2013
• Last Update Posted: April 17, 2013
• Last Verified: April 2013

Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:

Tight; Glycemic; control; outcomes; peripheral vascular disease; infection; cardiovascular; morbidity; mortality

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Vascular Diseases; Aortic Aneurysm, Abdominal; Peripheral Vascular Diseases; Peripheral Arterial Disease; Cardiovascular Diseases; Aortic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Physiological Effects of Drugs