DiabetesNCT01831154

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

A study testing Tight Glycemic, Conventional Glycemic and Standard Glycemic in people with Diabetes and Hyperglycemia, run by James A. Haley Veterans Administration Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Diabetes, Hyperglycemia, Surgical Site Infection
What is being tested?: Tight Glycemic, Conventional Glycemic and Standard Glycemic
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: May 2010to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

James A. Haley VAH
Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Diabetes, Hyperglycemia, Surgical Site Infection
Being tested: Tight Glycemic, Conventional Glycemic, Standard Glycemic
Keywords: Glycemic control
Medical subject headings: Diabetes Mellitus, Hyperglycemia, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tight GlycemicDrug
The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.
Conventional GlycemicDrug
The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.
Standard GlycemicDrug
Insulin was Regular Insulin administered intravenous bolus.

Study groups in NCT01831154
Study group	Role	What they receive
Tight Glycemic Group	Experimental	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. Receives: Drug: Tight Glycemic
Conventional Glycemic Group	Experimental	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. Receives: Drug: Conventional Glycemic
Standard Glycemic Group	Experimental	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. Receives: Drug: Standard Glycemic

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: six weeks postoperatively
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.
Measured: Post CPB and Postoperative days 1 through 5
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.
Measured: Post cardiopulmonary bypass and postoperative day 1 through 5

Secondary outcomes (3)

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Oct 2011

First posted15 Apr 2013 (estimated)
Study startMay 2010
Primary completionJul 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01831154
Sponsor's protocol ID: 106219
Status last verified: Mar 2017
First submitted: 9 Apr 2013
Last updated: 24 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intraoperative Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery
ClinicalTrials.gov ID: NCT01831154
Acronym / sponsor ID: 106219
Conditions: Diabetes, Hyperglycemia, Surgical Site Infection
Keywords: Glycemic control
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: James A. Haley Veterans Administration HospitalUS federal agency
Collaborators: University of South Florida
Study start: May 2010
Primary completion: Jul 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 15 Apr 2013 (estimated)
Results: Posted 24 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Tight Glycemic Group	Experimental	Drug: Tight GlycemicThe 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.
Conventional Glycemic Group	Experimental	Drug: Conventional GlycemicThe 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.
Standard Glycemic Group	Experimental	Drug: Standard GlycemicThe 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

chronically immunosuppressed
suffered from end-stage organ disease
currently had active infections
underwent emergent or salvage CABG surgery
had an implanted insulin pump

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tight GlycemicThe insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Drug	Tight Glycemic Group
Conventional GlycemicThe insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.	Drug	Conventional Glycemic Group
Standard GlycemicInsulin was Regular Insulin administered intravenous bolus.	Drug	Standard Glycemic Group

Primary outcome

Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection
Time frame: six weeks postoperatively
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.
The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery
Time frame: Post CPB and Postoperative days 1 through 5
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.
The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery
Time frame: 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.

3 secondary outcomes

Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery
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
The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery
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
Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.
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

Results and safety

Results posted to the registry on 24 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tight Glycemic Group	15	15
Conventional Glycemic Group	11	11
Standard Glycemic Group	11	11

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

Time frame: six weeks postoperatively. Number. Unit: participants

Measure	Tight Glycemic Group n = 15	Conventional Glycemic Group n = 11	Standard Glycemic Group n = 11
Value	4	5	5

Tight Glycemic Group vs Conventional Glycemic Group vs Standard Glycemic Group: p = 0.512, Chi-squared

Population analysed: 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.

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

Time frame: Post CPB and Postoperative days 1 through 5. Mean (Standard Deviation). Unit: ng/ml

Measure	Tight Glycemic Group n = 11	Conventional Glycemic Group n = 10	Standard Glycemic Group n = 10
Value	0.466 (0.448)	1.15 (0.981)	1.082 (0.581)

Tight Glycemic Group vs Conventional Glycemic Group vs Standard Glycemic Group: p = 0.024, ANOVA

Population analysed: 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).

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

Time frame: Post cardiopulmonary bypass and postoperative day 1 through 5. Mean (Standard Deviation). Unit: Mg/L

Measure	Tight Glycemic Group n = 11	Conventional Glycemic Group n = 10	Standard Glycemic Group n = 10
Value	13.11 (3.52)	10.95 (3.48)	13.98 (4.22)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study period including follow up was for 16 months in time, June 2010 through October 2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tight Glycemic Group	4 of 15 (26.7%)	0 of 15 (0%)	Not reported
Conventional Glycemic Group	1 of 11 (9.1%)	0 of 11 (0%)	Not reported
Standard Glycemic Group	5 of 11 (45.5%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was conducted in a single center and homogenous sample. Statistical power was not sufficient to draw conclusion on the effect of tight glycemic control on postoperative outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sierra A Gower, PhD principal investigator

James A Haley VAH

Theresa Beckie, PhD study chair

University of South Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection (time frame: six weeks postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.