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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01831154
Enrollment
37
Registered
2013-04-15
Start date
2010-05-31
Completion date
2011-10-31
Last updated
2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperglycemia, Surgical Site Infection

Keywords

Glycemic control

Brief summary

The purpose of this study was to investigate the effects of three different glycemic treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1) postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive protein levels in patients undergoing open-heart surgery. Secondary aims of the study were to investigate the effects of the three glycemic treatment conditions on: 1) intraoperative blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of stay, in patients undergoing open-heart surgery.

Detailed description

An experimental design with a multilevel, single factor, within-subjects design was utilized. Patients were nested within anesthesia provider teams. The design was counterbalanced by means of a Latin square, where each of three anesthesia provider teams dispensed each of three glycemic treatment conditions once.

Interventions

DRUGTight Glycemic

The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.

DRUGConventional Glycemic

The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.

DRUGStandard Glycemic

Insulin was Regular Insulin administered intravenous bolus.

Sponsors

University of South Florida
CollaboratorOTHER
James A. Haley Veterans Administration Hospital
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* over the age of 21 * on cardiopulmonary bypass or off cardiopulmonary * elective or urgent coronary artery bypass graft (CABG) surgery * CABG with or without combined valve surgery * valve surgery

Exclusion criteria

* chronically immunosuppressed * suffered from end-stage organ disease * currently had active infections * underwent emergent or salvage CABG surgery * had an implanted insulin pump * were in another interventional clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infectionsix weeks postoperativelyThe 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.
The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart SurgeryPost CPB and Postoperative days 1 through 5Procalcitonin 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.
The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart SurgeryPost cardiopulmonary bypass and postoperative day 1 through 5C-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.

Secondary

MeasureTime frameDescription
Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart SurgeryBlood glucose measured every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes, whichever event occurred firstBlood 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.
The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart SurgeryICU 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 wardLength of stay (LOS) in the intensive care unit was measured by the total number of days each patient stayed in the intensive care unit.
Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.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 firstIntraoperative 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
15
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.
11
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.
11
Total37

Baseline characteristics

CharacteristicTotalTight Glycemic GroupConventional Glycemic GroupStandard Glycemic Group
Age, Continuous65 years
STANDARD_DEVIATION 6.1
64 years
STANDARD_DEVIATION 6.9
66 years
STANDARD_DEVIATION 7.4
66 years
STANDARD_DEVIATION 4
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants14 Participants9 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
36 Participants15 Participants11 Participants10 Participants
Region of Enrollment
United States
37 participants15 participants11 participants11 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
37 Participants15 Participants11 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 150 / 110 / 11
serious
Total, serious adverse events
4 / 151 / 115 / 11

Outcome results

Primary

Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Tight Glycemic GroupNumber of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection4 participants
Conventional Glycemic GroupNumber of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection5 participants
Standard Glycemic GroupNumber of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection5 participants
Comparison: Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.p-value: 0.512Chi-squared
Primary

The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery

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.

Time frame: Post cardiopulmonary bypass and postoperative day 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).

ArmMeasureValue (MEAN)Dispersion
Tight Glycemic GroupThe Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery13.11 Mg/LStandard Deviation 3.52
Conventional Glycemic GroupThe Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery10.95 Mg/LStandard Deviation 3.48
Standard Glycemic GroupThe Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery13.98 Mg/LStandard Deviation 4.22
Primary

The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery

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.

Time frame: 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).

ArmMeasureValue (MEAN)Dispersion
Tight Glycemic GroupThe Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery0.466 ng/mlStandard Deviation 0.448
Conventional Glycemic GroupThe Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery1.15 ng/mlStandard Deviation 0.981
Standard Glycemic GroupThe Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery1.082 ng/mlStandard Deviation 0.581
p-value: 0.024ANOVA
Secondary

Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery

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.

Time frame: 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

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.

ArmMeasureValue (MEAN)Dispersion
Tight Glycemic GroupIntraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery130.77 mg/dlStandard Deviation 22.04
Conventional Glycemic GroupIntraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery143.33 mg/dlStandard Deviation 29.59
Standard Glycemic GroupIntraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery145.55 mg/dlStandard Deviation 35.15
p-value: 0.132ANOVA
Secondary

Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Tight Glycemic GroupIntraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.2 episodes out of target glucose range
Conventional Glycemic GroupIntraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.1 episodes out of target glucose range
Standard Glycemic GroupIntraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.1 episodes out of target glucose range
Secondary

The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery

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.

Time frame: 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

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.

ArmMeasureValue (MEAN)Dispersion
Tight Glycemic GroupThe Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery7 daysStandard Deviation 5.29
Conventional Glycemic GroupThe Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery6.18 daysStandard Deviation 4.9
Standard Glycemic GroupThe Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery7.18 daysStandard Deviation 6.03
p-value: 0.908ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026