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

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).

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease, Diabetes
• Intervention / Treatment: Other: Off-Pump Coronary Artery Bypass (OPCAB) surgery

• Study Type: Observational
• Enrollment (Actual): 703

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of preoperative diabetes mellitus

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
Operative mortality	all deaths, regardless of cause	during the hospitalization for surgery (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: May 20, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 4-2018-0221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No