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

NCT01831154 | Completed Results DMC

• 1 other identifier: 106219
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hyperglycemia; Surgical Site Infection

Keywords

Glycemic control

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Post cardiopulmonary bypass and postoperative day 1 through 5

Secondary Outcomes (3)

• Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery

  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

  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.

  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

Study Arms (3)

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.

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.

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.

Drug: Standard Glycemic

Interventions

Tight Glycemic DRUG

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

Tight Glycemic Group

Conventional Glycemic DRUG

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

Conventional Glycemic Group

Standard Glycemic DRUG

Insulin was Regular Insulin administered intravenous bolus.

Standard Glycemic Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• James A. Haley Veterans Administration Hospital: lead
• University of South Florida: collaborator

Study Sites (1)

James A. Haley VAH

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Sierra Gower
• Organization: James A Haley Veterans Hosptial

sierra.gower@va.gov

(813) 972-2000

Study Officials

• Sierra A Gower, PhD

  James A Haley VAH

  PRINCIPAL INVESTIGATOR

• Theresa Beckie, PhD

  University of South Florida

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 15, 2013
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 24, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-03

Locations

US (1)