Clinical trial NCT01831154: The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery
Official title: The Effect of Intraoperative Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hyperglycemia
Surgical Site Infection
Keywords: Glycemic control
Lead sponsor: James A. Haley Veterans Administration Hospital
Sponsor class: FED
Collaborators: name: University of South Florida
First posted: 2013-04-15
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection
timeFrame: six weeks postoperatively
measure: The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery
timeFrame: Post CPB and Postoperative days 1 through 5
measure: The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery
timeFrame: Post cardiopulmonary bypass and postoperative day 1 through 5
Secondary outcomes:
measure: Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery
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
measure: The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery
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
measure: Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.
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
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley VAH
state: Florida
Study officials:
affiliation: James A Haley VAH
name: Sierra A Gower, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Theresa Beckie, PhD
role: STUDY_CHAIR
References: