Clinical trial NCT03543449: Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.
Official title: Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease, Diabetes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 703
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of preoperative diabetes mellitus

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Permanent stroke
timeFrame: during the hospitalization for surgery (up to 30 days)
measure: Incidence of Renal failure
timeFrame: during the hospitalization for surgery (up to 30 days)
measure: Incidence of Prolonged ventilation
timeFrame: during the hospitalization for surgery (up to 30 days)
measure: Incidence of Deep sternal wound infection
timeFrame: during the hospitalization for surgery (up to 30 days)
measure: Incidence of Re-operation for any reason
timeFrame: during the hospitalization for surgery (up to 30 days)
measure: Operative mortality
timeFrame: during the hospitalization for surgery (up to 30 days)
Secondary outcomes:
measure: Perioperative Coefficient of variation of glucose
timeFrame: During surgery and up to the first 24 hours after surgery
measure: Incidence of Perioperative Coefficient of variation of glucose
timeFrame: During surgery and up to the first 24 hours after surgery
measure: Perioperative mean glucose
timeFrame: During surgery and up to the first 24 hours after surgery
measure: Perioperative time-weighted average glucose
timeFrame: During surgery and up to the first 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Study officials:
References: