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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831154
• Other study ID #: 106219
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: April 10, 2013
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2013
• Source: James A. Haley Veterans Administration Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
United States	James A. Haley VAH	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
James A. Haley Veterans Administration Hospital	American Association of Nurse Anesthetists, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of Intraoperative Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery.	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	No
Primary	The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin and C-reactive Protein plasma levels in Patients Undergoing Open Heart Surgery	Procalcitonin and C-reactive protein concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected the morning of surgery, 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, and trended over the six-day period.	Postoperative days 1 through 5	No
Secondary	The Effect of Intraoperative Tight Glycemic Control on 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.	Intraoperative	Yes
Secondary	The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery	Length of intensive care unit stay was measured by the total number of days each patient stayed in the intensive care unit. On average this was 5-7 days.	Number of ICU days, on average 5- 7 days	No
Secondary	The Effect of Intraoperative Tight Glycemic Control on Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery	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 or, the preset target ranges, for each protocol, 3 consecutive blood glucoses (1.5 hours) despite insulin therapy a marker of inadequate glycemic control was recorded.	Intraoperative	Yes