Trial Outcomes & Findings for The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery (NCT NCT01831154)

Last Updated: 2017-04-24

Results Overview

The presence or absence of deep, or/and superficial sternal wound infection and deep, superficial harvest site infection within in six weeks postoperatively was a primary outcome variable. Infection assessment was performed during the intensive care phase, at hospital discharge, two-week post hospital discharge and six-week post hospital discharge by independent blinded researchers that were part of the cardiothoracic team.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

six weeks postoperatively

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Tight Glycemic Group The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
Overall Study STARTED	15	11	11
Overall Study COMPLETED	15	11	11
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tight Glycemic Group n=15 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=11 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=11 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.	Total n=37 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 6.9 • n=5 Participants	66 years STANDARD_DEVIATION 7.4 • n=7 Participants	66 years STANDARD_DEVIATION 4 • n=5 Participants	65 years STANDARD_DEVIATION 6.1 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	11 participants n=7 Participants	11 participants n=5 Participants	37 participants n=4 Participants

PRIMARY outcome

Timeframe: six weeks postoperatively

Population: Inclusion \> age 21, underwent elective or urgent Coronary Artery Bypass Graft (CABG) with or without combined valve surgery or valve surgery alone, on or off cardiopulmonary bypass (CPB). Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.

Outcome measures

Outcome measures
Measure	Tight Glycemic Group n=15 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=11 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=11 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection	4 participants	5 participants	5 participants

PRIMARY outcome

Timeframe: Post CPB and Postoperative days 1 through 5

Population: Inclusion \> age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had \> 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).

Procalcitonin concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All procalcitonin blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean procalcitonin values with standard deviation.

Outcome measures

Outcome measures
Measure	Tight Glycemic Group n=11 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=10 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=10 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery	0.466 ng/ml Standard Deviation 0.448	1.15 ng/ml Standard Deviation 0.981	1.082 ng/ml Standard Deviation 0.581

PRIMARY outcome

Timeframe: Post cardiopulmonary bypass and postoperative day 1 through 5

C-Reactive Protein concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All C-Reactive Protein blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean C-Reactive Protein values with standard deviation.

Outcome measures

Outcome measures
Measure	Tight Glycemic Group n=11 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=10 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=10 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery	13.11 Mg/L Standard Deviation 3.52	10.95 Mg/L Standard Deviation 3.48	13.98 Mg/L Standard Deviation 4.22

SECONDARY outcome

Timeframe: Blood glucose measured every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes, whichever event occurred first

Blood glucose values were obtained every 30 minutes in the intraoperative period, and were drawn and recorded by the certified registered nurse anesthetist (CRNA) performing the anesthetic. Repeated measured ANOVA with Greenhouse-Geisser correction was employed to determine if participants assigned to the tight glycemic group yielded lower blood glucose levels intraoperatively (every 30 minutes for 240 minutes) than the other two interventions. All blood glucose measures over the intraoperative period were averaged to produce a mean and standard deviation comparing the tight glycemic group to the other two interventional groups, Data points were blood glucose testing collected every 30 minutes starting on entry into the operating room.

Outcome measures

Outcome measures
Measure	Tight Glycemic Group n=15 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=11 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=11 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery	130.77 mg/dl Standard Deviation 22.04	143.33 mg/dl Standard Deviation 29.59	145.55 mg/dl Standard Deviation 35.15

SECONDARY outcome

Timeframe: ICU days measured every day the patient stayed in ICU starting with entry into the ICU from the Operating Room until discharge from the ICU to the ward

Length of stay (LOS) in the intensive care unit was measured by the total number of days each patient stayed in the intensive care unit.

Outcome measures

Outcome measures
Measure	Tight Glycemic Group n=15 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=11 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=11 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery	7 days Standard Deviation 5.29	6.18 days Standard Deviation 4.9	7.18 days Standard Deviation 6.03

SECONDARY outcome

Timeframe: Measures of blood glucose every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes whichever event occurred first

Population: Inclusion \> age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. No data analysis could be performed because there were too few episodes of glycemic instability.

Intraoperative glycemic stability was operationalize as how often blood glucose levels were maintained as normal or maintained in the preset target ranges for each group. If intraoperative blood glucose levels fell outside of normal (hypoglycemia or hyperglycemia) or, outside the preset target ranges, for each protocol, for 3 consecutive blood glucoses (1.5 hours) despite insulin therapy a marker of inadequate glycemic control was recorded.

Outcome measures

Outcome measures
Measure	Tight Glycemic Group n=15 Participants The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=11 Participants The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=11 Participants The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.	2 episodes out of target glucose range	1 episodes out of target glucose range	1 episodes out of target glucose range

Adverse Events

Tight Glycemic Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Glycemic Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Glycemic Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tight Glycemic Group n=15 participants at risk The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control. Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Conventional Glycemic Group n=11 participants at risk The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Standard Glycemic Group n=11 participants at risk The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU. Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus.
Cardiac disorders Atrial Fibrillation	13.3% 2/15 • Number of events 4 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 4 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 4 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Nervous system disorders Cerebral vascular accident (CVA)	6.7% 1/15 • Number of events 2 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 2 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Infections and infestations Deep sternal wound infection	0.00% 0/15 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	18.2% 2/11 • Number of events 2 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	6.7% 1/15 • Number of events 2 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 2 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Cardiac disorders Chest pain	0.00% 0/15 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 1 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Skin and subcutaneous tissue disorders Feet Ulcerations	0.00% 0/15 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 1 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Gastrointestinal disorders Viral gastrointestinal-dehydration	6.7% 1/15 • Number of events 1 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
Cardiac disorders Congestive heart failure	0.00% 0/15 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	9.1% 1/11 • Number of events 1 • The study period including follow up was for 16 months in time, June 2010 through October 2011.
General disorders Death	6.7% 1/15 • Number of events 1 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.	0.00% 0/11 • The study period including follow up was for 16 months in time, June 2010 through October 2011.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sierra Gower

James A Haley Veterans Hosptial

Phone: (813) 972-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place