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Ann Thorac Surg 2005;80:902-909
© 2005 The Society of Thoracic Surgeons

Original article: Cardiovascular

Implementing Tight Glucose Control After Coronary Artery Bypass Surgery

Justine M. Carr, MD a , b , * , Frank W. Sellke, MD a , Michelle Fey, NP a , Mathew J. Doyle, MA b , Judy A. Krempin, MS a , Ralph de la Torre, MD a , John R. Liddicoat, MD a

a Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts
b Department of Health Care Quality, Beth Israel Deaconess Medical Center, Boston, Massachusetts

Accepted for publication March 23, 2005.

* Address reprint requests to Dr Carr, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston MA 02215 (Email: jcarr{at}bidmc.harvard.edu).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: The clinical benefit of tight glucose control has been demonstrated in diabetic patients. In adopting an approach of tight glucose control for all cardiac surgery patients at Beth Israel Deaconess Medical Center, we encountered several challenges, including defining good glucose control, meaningfully measuring control, and assessing the impact of variables that may affect control.

METHODS: An interdisciplinary team used an insulin protocol to achieve tight glucose control of cardiac surgery patients in the operating room and intensive care unit as part of an effort to reduce sternal wound infections. Good control was defined as glucose less than 130 mg/dL for more than 50% of measured time.

RESULTS: Eight hundred eighteen patients underwent coronary artery bypass grafting between November 2002 and August 2004. Seven hundred thirty-seven (90%) received insulin. Fifty-seven percent did not have a preoperative diagnosis of diabetes. The trigger for insulin initiation was decreased sequentially from 150 mg/dL to 110 mg/dL, but the measure of good control remained the same: glucose less than 130 mg/dL. The factor most highly predictive of glucose being well controlled was the protocol with the 110 mg/dL trigger for insulin (p < 0.001). Patient factors such as age, ejection fraction, preoperative angiotensin-converting enzyme inhibitor or ß-blocker use, or time on cardiopulmonary bypass were not significantly associated with glucose control. During the course of the protocols, the rate of mediastinitis decreased from 1.6% to 0%.

CONCLUSIONS: Key elements to implementing tight glucose control include having a standard protocol and metrics to track protocol performance. This practice improved control and was associated with a marked reduction in mediastinitis.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
The clinical benefit of long-term tight glucose control has been demonstrated in diabetic patients, with an associated reduction in chronic complications such as retinopathy, neuropathy, and nephropathy [1]. In recent years, it has also been recognized that tight glucose control markedly improves acute outcomes of hospitalized diabetic patients, including lowering the risk of infection and death [2–7]. Reports have demonstrated that tight glucose control with continuous intravenous insulin in diabetic cardiac surgery patients reduces mediastinitis, mortality, costs, and length of stay [2, 3, 8, 9]. Lazar and colleagues [5] showed there was also a reduction in postoperative atrial fibrillation and ischemia in cardiac surgery patients. There are now reports demonstrating the outcome benefits of tight glucose control in hospitalized patients, even in the absence of diabetes [9–16]. In 2001, we initiated a program to tightly control glucose levels in cardiac surgery patients in an effort to reduce the rate of wound infection. In adopting this practice at Beth Israel Deaconess Medical Center, we encountered several operational challenges. These included defining good glucose control, meaningfully measuring control, tracking performance, and assessing the impact of variables that may affect control. This study addresses each of these issues and proposes a strategy to implement tight glucose control.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
In January 2001, an interdisciplinary team began a systematic review of opportunities to improve outcomes of patients undergoing cardiac surgery. The team included surgeons, anesthesiologists, diabetologists, intensive care unit (ICU) nurses, nurse practitioners, and physician assistants and staff from Health Care Quality, Infection Control, and Decision Support. One area of focus was reduction of mediastinitis. Improvement initiatives included changes in preoperative scrub (April 2001), prep and drape (April 2001), and preoperative antibiotics (May 2001 and February 2003). In May 2001 the team developed an insulin protocol to achieve tight glucose control of postoperative cardiac surgery patients in the ICU. Assessment of the benefit of the protocol was suboptimal because adherence and impact could only be measured by selected chart review on individual patients. In November 2002 automated reports of glucose values became available, providing clinicians with performance data that were comprehensive, automated, current, and available monthly. Trended data were reviewed each month by the interdisciplinary team and assessed for achievement of target glucose control. The ICU nurses further reviewed specific patient data in detail.

All patients undergoing cardiac surgery were admitted to the ICU for their early recovery period. Patients whose recovery was uncomplicated generally stayed 1 to 2 days after which they were transferred to a regular monitored bed. Hourly glucose measurement was the goal. To ensure comparability, performance metrics included only glucose values from the first 48 hours. The protocol, however, continued throughout the ICU stay. This report summarizes the experience of all patients who underwent coronary artery bypass graft (CABG) surgery between November 2002 and August 2004. Approval was obtained from the Beth Israel Deaconess Medical Center Committee on Clinical Investigations in September 2004 for retrospective review.

Insulin Protocols
Preoperatively, glucose was measured as part of routine admission laboratory tests with no standardized intervention. Intraoperatively, patients with elevated glucose received insulin per anesthesia protocol. Briefly, glucose was checked hourly and values greater than 125 mg/dL were treated with insulin (infusion for known diabetics and intravenous boluses for nondiabetics). Before institution of the anesthesia protocol, intraoperative glucose values of up to 200 mg/dL were acceptable. Postoperatively, on arrival in the ICU, patients underwent immediate glucose assessment using Johnson & Johnson’s LifeScan SureStepPro glucometer (Milpitas, CA), test strips, and controls. Patients with glucose greater than the trigger value were treated according to the ICU insulin protocol. The latest version of this ICU protocol is shown in Table 1. Trigger for insulin initiation was decreased sequentially: phase I, 150 mg/dL began in November 2002; phase II, 125 mg/dL began in March 2003; and phase III, 110 mg/dL began in February 2004. The initial trigger of 150 mg/dL was selected as a conservative consensus of the team. The phase II trigger of 125 mg/dL resulted from review of the data and the desire to bring more patients into control more quickly. Phase III trigger of 110 mg/dL was adopted to better align with published recommendations and also because the nurses had developed efficiency and expertise in the implementation of the protocol [10, 17].


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  		Table 1. Intensive Care Unit Insulin Protocol a
 
Metrics
All ICU glucose values were entered into the CareVue 9000 Clinical Information System (Hewlett Packard, Palo Alto, CA). All results were later downloaded into a Microsoft Access (Microsoft Corp, Redmond, WA) database for analysis. A formula was developed to assess the percent of time a patient was in control (glucose < 130 mg/dL) up to the first 48 hours in the ICU. The metric of glucose less than 130 mg/dL as evidence of control was instituted in phase I and continued throughout phases II and III. Intensive care unit glucose control was tracked for each CABG patient who received insulin and had more than three glucose values. Briefly, hourly glucose values were designated as either in control or out of control. To correct for hours in which a glucose value was missed or was repeated within a shorter time, a correction formula was developed (Fig 1). Patients were considered to be well controlled when glucose was less than 130 mg/dL more than half of the time. Patients were considered to be poorly controlled when glucose was less than 130 mg/dL less than or equal to half of the time. Patient variables, medications, surgical pump times, and protocol variables were analyzed by {chi}2 and linear regression analysis to assess their impact on whether patients were well controlled or poorly controlled.



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  		Fig 1. Formula for determining percent of time in glucose control.

 
Sternal infections in cardiac surgery patients were identified and categorized as superficial, deep, or organ space by Infection Control staff as part of routine surveillance. Infections were reported per 100 operations, hereafter referred to as percent. Organ space infections (mediastinitis) include surgical site infections within one year of surgery that involve "any part of the anatomy (eg, organs or spaces), other than the incision, opened or manipulated during the operative procedure" [18]. These included cases for which an organism was cultured and the sternum was involved.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
Eight hundred eighteen patients underwent CABG between November 2002 and August 2004. Of these patients, 737 (90%) received insulin for glucose control. Four hundred twenty-three patients (57%) did not have a preoperative diagnosis of diabetes.

Protocol Impact
The glucose value that triggered initiation of insulin was lowered three times (Fig 2). The assessment of control (glucose < 130 mg/dL) was established at the start and remained the same throughout the protocol. Once metrics became available in November 2002, it was noted that despite having had a protocol in place since May 2001, only 35% of patients were well controlled. During phase I (November 2002 to February 2003) the trigger for insulin was glucose greater than 150 mg/dL, and 82% of CABG patients received insulin. The percent of well-controlled patients increased from 35% to an average of 49%, and the mediastinitis rate decreased to 1.0% (Table 2). During phase II (March 2003 to January 2004) the insulin trigger was glucose greater than 125 mg/dL, and 89% of CABG patients received insulin. The percent of well-controlled patients increased to an average of 59% (Fig 2). Mediastinitis rate fell to 0.4% and no case of mediastinitis occurred after April 2003 (Table 2). During phase III (February 2004 to August 2004) the insulin trigger was decreased to glucose greater than 110 mg/dL, and 98% of CABG patients received insulin. The percent of well-controlled patients increased to an average of 75% (Fig 2). No cases of mediastinitis were seen during phase III (Table 2).



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  		Fig 2. Percent of coronary artery bypass graft (CABG) patients in control (<130 mg/dL) more than 50% of the time in phases I, II and III.

 

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  		Table 2. Infection Prevention Measures
 
The other infection control initiatives are summarized in Table 2. Although there was a change in the antibiotic prophylaxis protocol in February 2003, it was not considered to be a major contributor to the decline in organ space infections. The February 2003 change was to add gram-negative coverage for patients who were not same-day admission status. Only 5% of the organ space infections between May 2001 and January 2003 would have been eliminated had the change in antibiotics been put in place earlier. Review of all organ space infections from fiscal years 2001 through 2003 revealed that 96% of patients had postoperative glucose values greater than 130 mg/dL. The known diabetics (52% of patients) were in control 35% of time, and the nondiagnosed diabetics were in control 42% of time.

As the trigger glucose was lowered and more patients were treated with insulin, there appeared to be a decline in the percentage of patients who had any glucose greater than 200 mg/dL between phase I and phase III, although this was not significant (p = 0.074). There was no significant change in the percentage of patients who had any glucose less than 50 mg/dL (p = 0.335; Fig 3). Review of all treated patients revealed that 57 (7.7%) had a total of 70 glucoses less than 50 mg/dL. Median time to restoration of glucose to a level greater than 50 mg/dL was 30 minutes.



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  		Fig 3. Minimum and maximum glucose values per patient by month. Includes patients who had any glucose value in the stated range, either greater than 200 mg/dL or less than or equal to 50 mg/dL.

 
As a result of the anesthesia intraoperative protocol, the percent of patients arriving in the ICU from the operating room with a glucose greater than 200 mg/dL decreased from phase I to phase III (p = 0.045; Fig 4).



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  		Fig 4. First glucose on arrival in the intensive care unit represents intraoperative control of glucose.

 
Factors Affecting Glucose Control
In an effort to identify factors associated with successful perioperative glucose control, we analyzed factors related to the patient, medications, surgery, and protocol. The regression analysis results are summarized in Table 3 and detailed in Table 4.


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  		Table 3. Predictors of Good Glucose Control
 

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  		Table 4. Association of Factors With Level of Control
 
The most important factor associated with patients who were well controlled was the protocol, with an increase in the percentage of well-controlled patients as the threshold for initiation of insulin decreased. The next factor was the hours between the first and last glucose measurement, with well-controlled patients having a slightly shorter duration (37.8 hours versus 38.1 hours). The third factor was the number of tests per patient, with well-controlled patients having more tests (23.6 versus 21.5). The fourth factor was the presence or absence of diabetes, with fewer diabetic patients in the well-controlled group. Notable, however, is that 149 of 423 nondiabetic patients (35%) were in the poorly controlled group. The fifth factor was glucose on arrival in the ICU, reflecting intraoperative glucose control. Having an initial glucose less than 200 mg/dL was associated with being well controlled, but glucose on arrival of less than 150 mg/dL was not. The final factor associated with being well controlled was infusion of inotropic agent on arrival in the ICU, including milrinone, epinephrine, dobutamine, Levophed, or dopamine.

Factors that were not significant included patient age, ejection fraction, preoperative angiotensin-converting enzyme inhibitor or ß-blocker, and cardiopulmonary bypass time. Subset analysis of the 423 patients who were nondiabetic showed a similar pattern to the full group. One difference is that among the nondiabetic patients, the average age of the poorly controlled patients was slightly older than the well-controlled patients (69.8 versus 67.3 years; p = 0.027).

Protocol Compliance
The ratio of the number of glucose tests to the number of hours in the ICU was calculated. The ratio was then converted into an average time frequency interval (Table 5). Overall, 58% of the patients had glucose measured more frequently than every 2 hours during their first 48 hours. The average time between tests shortened with each protocol phase: phase I, 141 minutes; phase II, 122 minutes; and phase III, 118 minutes.


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  		Table 5. Compliance With Hourly Glucose Measurement
 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
In this retrospective analysis, we found that tight glucose control was facilitated by multidisciplinary teamwork focused on three factors: definition of a target glucose, standardized insulin protocol and tracking of achievement of target glucose. Tight glucose control was one of several initiatives to reduce mediastinal organ space infections. There was an associated fall in mediastinal organ space infections as glucose control improved.

The value of tight glucose control in the postoperative period is well established [1–12]. The American Association of Clinical Endocrinologists recommends maintaining critical care patients at euglycemic levels less than 110 mg/dL [17, 19]. The challenge is no longer the acceptance of this approach, but rather the implementation. Our first task was to choose a target glucose. Selection of glucose less than 130 mg/dL was empiric, but proved to be satisfactory, even though it was not as aggressive as recent recommendations. This choice was made based on the literature and on the comfort level of the clinical staff. Various glucose values and ranges have been associated with clinical benefit including less than 220 mg/dL [7], less than 200 mg/dL, less than 175 mg/dL or less than 150 mg/dL [3, 8], 126 to 180 mg/dL [8], or 80 to 110 mg/dL [10].

The second challenge was creating a protocol. The key issues were the selection of the trigger glucose for the initiation of insulin and the change in nursing care processes to accommodate frequent glucose measurement. Similar to the Portland group, we found that frequent measurement played a critical role in maintaining control [9]. Constant feedback and dialogue facilitated adjustments to the protocol and adherence by the nursing staff. The goal of hourly measurement during the first 48 hours was achieved less than 20% of the time; however, more than half of the patients had glucose measurement at least every 2 hours. Some of the variation from the protocol was attributable to the early phases when the practices were new. Indeed the average time between tests shortened from phase I through phases II and III. Choosing the trigger for insulin must be closely linked with the capacity to perform frequent glucose measurements. Of note is that with the lowering of the insulin trigger to 110 mg/dL in phase III, there was an apparent increase in frequency of episodes of hypoglycemia, although not statistically significant. The lower the trigger glucose, the greater is the need for regular measurement to avoid hypoglycemia.

The third key challenge was the development of metrics to track control. Although the first protocol was developed in May 2001, there was no way to systematically assess its effectiveness until November 2002. Assessment of glucose control has been reported in the literature in a variety of ways, including maximum glucose [3], average for day of surgery through day 3 [8], morning glucose [10], and percent glucose within range and area under the curve less than 150 mg/dL for the first 24 hours [13]. In November 2002 our selection of the metric, percent of time in control, provided more information about the adherence to the protocol than would a single value or a daily average. Despite the longstanding protocol, in November 2002 patients were found to be in control only 35% of the time. A benefit of the automated data was that it was complete, quantitative, and available in real time. Trended monthly data demonstrated overall performance of the protocol. The beneficial impact of lowering the insulin trigger from 150 mg/dL to 125 mg/dL to 110 mg/dL was reflected by the increase in the percentage of patients in good control. Review of monthly reports created the opportunity for discussion and focus on effectiveness of protocol. Ability to drill down to individual results afforded the opportunity to assess compliance with the protocol. Variances led to educational efforts of individual nurses or adjustments of the protocol. Retrospective analysis of annual data afforded greater understanding of the impact of the initiative.

In addition to the ICU protocol, several other factors were associated with good control. The absence of a history of diabetes was associated with good control; however, 35% of nondiabetic patients were in the poorly controlled group, underscoring the fact that some nondiabetics can be difficult to control. Intraoperative glucose management impacted achievement of good control. Although glucose on arrival of less than 200 mg/dL was associated with good control, tighter control (glucose less than 150 mg/dL) was not predictive of being in the well-controlled group. This suggests that there may not be a benefit in trying to control glucose too tightly in the operating room. An unexpected finding was that patients receiving an inotropic agent on arrival in the ICU were in better control than those not receiving this medication. This seems counterintuitive as inotropic agents would stimulate a ß-receptor to raise glucose through gluconeogenesis. The observation deserves further evaluation.

The impetus for tight glucose control was reduction of infection. Although multiple infection control initiatives were ongoing throughout the 4 years, once tight glucose control was under way, we did not have a mediastinal organ space infection in greater than 16 months. Attention to established infection control measures (prep and drape, preoperative antibiotic selection and timing) yielded improvement. However, elimination of sternal organ space infection was not achieved until data-driven adherence to the protocol was established. Lowering the trigger for insulin initiation from 150 mg/dL to 125 mg/dL in March 2003 improved control (patients being in control an average of 59% of the time.) Within 6 weeks of lowering the insulin trigger to 125 mg/dL, there were no further cases of mediastinal organ space infections after CABG or any other cardiac surgery. This raises the question of whether subsequent lowering of the trigger to 110 mg/dL added further value or whether the trigger of 125 mg/dL was sufficient.

Achievement of tight glucose control can be facilitated by development of a protocol and monitoring the protocol with an automated metric and regular review by a clinical team. Our analysis shows that the trigger of 110 mg/dL for initiation of insulin therapy, as well as the frequent testing, plays a large part in achieving good control (glucose less than 130 mg/dL more than half the time). This was true for patients with or without diabetes mellitus. Tight glucose control was one of several initiatives undertaken to reduce sternal organ space infections. Although a causal relationship between glucose control and infection was not demonstrated in this review, an aggressive approach to tight perioperative control was associated with a significant decline in mediastinitis after CABG.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
We gratefully acknowledge the tremendous contribution of the entire cardiac surgery team and ICU staff and recognize the following individuals in particular for their insight and support of this effort: Kathleen Clark-Hussain, RN, Cardiac Surgery Recovery Unit; Gail Piatkowski, Decision Support; Mark Courtney, NP, Ronald Weintraub, MD, and William Cohn, MD, Cardiothoracic Surgery; John Mashikian, MD, and Adam Lerner, MD, Anesthesia; Robin Kalaidjian, RN, Infection Control; Kenneth Sands, MD, Health Care Quality; and Walid Fathi, MD, Joslin Diabetes Center.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus N Engl J Med 1993;329:304-309.[Abstract/Free Full Text]
  2. Zerr KJ, Furnary AP, Grunkemeier GL, Bookin S, Kanhere V, Starr A. Glucose control lowers the risk of wound infection in diabetics after open heart operations Ann Thorac Surg 1997;63:356-361.[Abstract/Free Full Text]
  3. 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;67:352-362.[Abstract/Free Full Text]
  4. Latham R, Lancaster AD, Covington JF, Pirolo JS, Thomas CS. The association of diabetes and glucose control with surgical site infections among cardiothoracic surgery patients Infect Control Hosp Epidemiol 2001;22:607-612.[Medline]
  5. Lazar HL, Chipkin SR, Fitzgerald CA, Bao Y, Cabral H, Apstein CS. Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events Circulation 2004;109:1497-1502.[Abstract/Free Full Text]
  6. Malmberg K, Ryden L, Efendie S, et al. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study)effects on mortality at 1 year. J Am Coll Cardiol 1995;26:57-65.[Abstract]
  7. Pomposelli J, Baxter J, Babineau T, et al. Early postoperative glucose control predicts nosocomial infection rate in diabetic patients J Parenter Enteral Nutr 1998;22:77-81.[Abstract]
  8. Furnary AP, Gao G, Grunkemeier GL, et al. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting J Thorac Cardiovasc Surg 2003;125:1007-1021.[Abstract/Free Full Text]
  9. Furnary AP, Wu Y, Bookin SO. Effect of hyperglycemia and continuous intravenous insulin infusions on outcomes of cardiac surgical proceduresPortland Diabetic Project. Endocr Pract 2004;10(Suppl 2):21-33.
  10. van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the critically ill patients N Engl J Med 2001;345:1359-1367.[Abstract/Free Full Text]
  11. Krinsley JS. Association between hyperglycemia and increased hospital mortality in a heterogeneous population of critically ill patients Mayo Clin Proc 2003;78:1471-1478.[Medline]
  12. Finney SJ, Zekveld C, Elias A, Evans TW. Glucose control and mortality in critically ill patients JAMA 2003;290:2041-2047.[Abstract/Free Full Text]
  13. Zimmerman CR, Mlynarek ME, Jordan JA, Rajda CA, Horst HM. An insulin infusion protocol in critically ill cardiothoracic surgery patients Ann Pharmacother 2004;38:1123-1129.[Abstract/Free Full Text]
  14. McMullin J, Brozek J, Jaeschke R, et al. Glycemic control in the ICUa multicenter survey. Intensive Care Med 2004;30:798-803.[Medline]
  15. Kanji S, Singh A, Tierney M, Meggison H, McIntyre L, Hebert PC. Standardization of intravenous insulin therapy improves the efficiency and safety of glucose control in critically ill adults Intensive Care Med 2004;30:804-810.[Medline]
  16. Schetz M, van den Berghe G. Glucose control in the critically ill Contrib Nephrol 2004;144:119-131.[Medline]
  17. American College of Endocrinology Consensus Conference on Glycemic Control Endocr Pract 2002;8(Suppl 1):5-11.[Medline]
  18. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Epmori TG. CDC definitions of nosocomial surgical site infections, 1992a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 1992;13:606-608.[Medline]
  19. American College of Endocrinology Position statement on inpatient diabetes and metabolic control Endocr Pract 2004;10(Suppl 2):77-82.[Medline]



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