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Clinical Trials/NCT03543449
NCT03543449
Unknown
Not Applicable

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

Yonsei University1 site in 1 country703 target enrollmentApril 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease, Diabetes
Sponsor
Yonsei University
Enrollment
703
Locations
1
Primary Endpoint
Incidence of Renal failure
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 23, 2018
End Date
April 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Incidence of Renal failure

Time Frame: during 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 stroke

Time Frame: during 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 ventilation

Time Frame: during 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 reason

Time Frame: during the hospitalization for surgery (up to 30 days)

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

Operative mortality

Time Frame: during the hospitalization for surgery (up to 30 days)

all deaths, regardless of cause

Incidence of Deep sternal wound infection

Time Frame: during the hospitalization for surgery (up to 30 days)

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

Secondary Outcomes

  • Perioperative Coefficient of variation of glucose(During surgery and up to the first 24 hours after surgery)
  • Perioperative time-weighted average glucose(During surgery and up to the first 24 hours after surgery)
  • Incidence of Perioperative Coefficient of variation of glucose(During surgery and up to the first 24 hours after surgery)
  • Perioperative mean glucose(During surgery and up to the first 24 hours after surgery)

Study Sites (1)

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