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Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.

Conditions
Coronary Artery Disease, Diabetes
Registration Number
NCT03543449
Lead Sponsor
Yonsei University
Brief Summary

The aim of this study is to evaluate evaluated the impact of preoperative HbA1c in diabetic patients on perioperative glycemic variability and outcome after off-pump coronary artery bypass (OPCAB).

The medical records of patients who had a preoperative diagnosis of diabetes and underwent OPCAB from 2005 to 2017 will be reviewed. Patients are divided by HbA1c levels (\<7.0% or ≥7.0%). Glycemic variability during surgery and up to 24 hours after surgery is assessed by the coefficient of variation. The primary outcome is defined as a composite of postoperative permanent stroke, prolonged ventilation, deep sternal wound infection, renal failure, reoperation, mortality according to the definition of STS (Society of Thoracic Surgery) version 2.81 adult cardiac surgery database. If one or more of the above five morbidity or mortality occur, it is assumed that composite morbidity/mortality had occurred. We compare postoperative complications, mortality and perioperative glycemic variability between patients with HbA1c ≥7.0% and \<7.0%, and examined the effects of perioperative glycemic control on postoperative morbidity and mortality (composite morbidity/mortality).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
703
Inclusion Criteria
  • Patients with a history of preoperative diabetes mellitus and with available results of HbA1c test within 3 months before surgery.
  • Patients who aged 20 to 89 years
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Exclusion Criteria
  • Patient who had a history of previous coronary artery bypass surgery
  • Patients whose surgery plan changed to cardiopulmonary bypass during surgery.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of Deep sternal wound infectionduring the hospitalization for surgery (up to 30 days)

Deep sternal wound infection or mediastinitis including muscle layer according to CDC definition

Incidence of Renal failureduring the hospitalization for surgery (up to 30 days)

1. Increase in serum creatinine level 3.0 x greater than baseline, or serum creatinine level ≥ 4 mg/dL. The acute rise must be at least 0.5 mg/dl.

2. A new requirement for dialysis postoperatively.

Incidence of Permanent strokeduring the hospitalization for surgery (up to 30 days)

postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.)

Incidence of Prolonged ventilationduring the hospitalization for surgery (up to 30 days)

Prolonged post-operative pulmonary ventilation \> 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.

Incidence of Re-operation for any reasonduring the hospitalization for surgery (up to 30 days)

reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason

Operative mortalityduring the hospitalization for surgery (up to 30 days)

all deaths, regardless of cause

Secondary Outcome Measures
NameTimeMethod
Perioperative Coefficient of variation of glucoseDuring surgery and up to the first 24 hours after surgery

the standard deviation divided by the average of blood glucose concentration during surgery and first 24 hours after surgery

Perioperative time-weighted average glucoseDuring surgery and up to the first 24 hours after surgery

time-weighted average of blood glucose concentration during surgery and first 24 hours after surgery

Incidence of Perioperative Coefficient of variation of glucoseDuring surgery and up to the first 24 hours after surgery

the standard deviation of blood glucose concentration during surgery and first 24 hours after surgery

Perioperative mean glucoseDuring surgery and up to the first 24 hours after surgery

average of blood glucose concentration during surgery and first 24 hours after surgery

Trial Locations

Locations (1)

Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

🇰🇷

Seoul, Korea, Republic of

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