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

NCT ID: NCT01831154

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-10-31

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.

Conditions

Diabetes; Hyperglycemia; Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tight Glycemic

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Conventional Glycemic

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Standard Glycemic

Intervention Type: DRUG

Insulin was Regular Insulin administered intravenous bolus.

Interventions

Tight Glycemic

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

Intervention Type: DRUG

Conventional Glycemic

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

Intervention Type: DRUG

Standard Glycemic

Insulin was Regular Insulin administered intravenous bolus.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

James A. Haley Veterans Administration Hospital

FED

Sponsor Role: lead

Responsible Party

Sierra Gower

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sierra A Gower, PhD

Role: PRINCIPAL_INVESTIGATOR

James A Haley VAH

Theresa Beckie, PhD

Role: STUDY_CHAIR

University of South Florida

Locations

James A. Haley VAH

Tampa, Florida, United States

Countries

United States

Other Identifiers

106219

Identifier Type: -

Identifier Source: org_study_id