Trials / Completed
CompletedNCT01831154
The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery
The Effect of Intraoperative Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- James A. Haley Veterans Administration Hospital · Federal
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tight Glycemic | The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline. |
| DRUG | Conventional Glycemic | The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline. |
| DRUG | Standard Glycemic | Insulin was Regular Insulin administered intravenous bolus. |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2011-07-01
- Completion
- 2011-10-01
- First posted
- 2013-04-15
- Last updated
- 2017-04-24
- Results posted
- 2017-04-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01831154. Inclusion in this directory is not an endorsement.