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N/A N=37 Randomized Double-blind Prevention

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

Diabetes · Hyperglycemia · Surgical Site Infection

Bottom Line

View on ClinicalTrials.gov: NCT01831154 ↗
Enrolled (actual)
37
Serious AEs
27.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection — 4; 5; 5 participants — p=0.512

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tight Glycemic (Drug); Conventional Glycemic (Drug); Standard Glycemic (Drug)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
James A. Haley Veterans Administration Hospital
Primary completion
Jul 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection		 4; 5; 5 0.512
PRIMARY
The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery		 0.466; 1.15; 1.082 0.024 sig
PRIMARY
The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery		 13.11; 10.95; 13.98 —
SECONDARY
Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery		 130.77; 143.33; 145.55 0.132
SECONDARY
The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery		 7; 6.18; 7.18 0.908
SECONDARY
Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.		 2; 1; 1 —

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01831154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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