Coronary Artery Disease, Diabetes Clinical Trial
Official title:
Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.
| Verified date | June 2018 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Active, not recruiting |
| Enrollment | 703 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 20 Years to 89 Years |
| Eligibility |
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 Exclusion Criteria: - Patient who had a history of previous coronary artery bypass surgery - Patients whose surgery plan changed to cardiopulmonary bypass during surgery. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Permanent stroke | 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.) | during the hospitalization for surgery (up to 30 days) | |
| Primary | Incidence of Renal failure | 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. A new requirement for dialysis postoperatively. |
during the hospitalization for surgery (up to 30 days) | |
| Primary | Incidence of Prolonged ventilation | 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. | during the hospitalization for surgery (up to 30 days) | |
| Primary | Incidence of Deep sternal wound infection | Deep sternal wound infection or mediastinitis including muscle layer according to CDC definition | during the hospitalization for surgery (up to 30 days) | |
| Primary | Incidence of Re-operation for any reason | reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason | during the hospitalization for surgery (up to 30 days) | |
| Primary | Operative mortality | all deaths, regardless of cause | during the hospitalization for surgery (up to 30 days) | |
| Secondary | Perioperative Coefficient of variation of glucose | the standard deviation divided by the average of blood glucose concentration during surgery and first 24 hours after surgery | During surgery and up to the first 24 hours after surgery | |
| Secondary | Incidence of Perioperative Coefficient of variation of glucose | the standard deviation of blood glucose concentration during surgery and first 24 hours after surgery | During surgery and up to the first 24 hours after surgery | |
| Secondary | Perioperative mean glucose | average of blood glucose concentration during surgery and first 24 hours after surgery | During surgery and up to the first 24 hours after surgery | |
| Secondary | Perioperative time-weighted average glucose | time-weighted average of blood glucose concentration during surgery and first 24 hours after surgery | During surgery and up to the first 24 hours after surgery |