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

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03543449
Collaborator
(none)
703
1
11.3
62.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Off-Pump Coronary Artery Bypass (OPCAB) surgery

Study Design

Study Type:
Observational
Actual Enrollment :
703 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.
Actual Study Start Date :
Apr 23, 2018
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Apr 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Incidence of Permanent stroke [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.)

  2. Incidence of Renal failure [during the hospitalization for surgery (up to 30 days)]

    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.

  3. Incidence of Prolonged ventilation [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.

  4. Incidence of Deep sternal wound infection [during the hospitalization for surgery (up to 30 days)]

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

  5. Incidence of Re-operation for any reason [during the hospitalization for surgery (up to 30 days)]

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

  6. Operative mortality [during the hospitalization for surgery (up to 30 days)]

    all deaths, regardless of cause

Secondary Outcome Measures

  1. Perioperative Coefficient of variation of glucose [During 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

  2. Incidence of Perioperative Coefficient of variation of glucose [During 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

  3. Perioperative mean glucose [During surgery and up to the first 24 hours after surgery]

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

  4. Perioperative time-weighted average glucose [During 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 89 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine Seoul Korea, Republic of 120-752

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT03543449
Other Study ID Numbers:
  • 4-2018-0221
First Posted:
Jun 1, 2018
Last Update Posted:
Jun 21, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2018