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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03543449
Other study ID # 4-2018-0221
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 23, 2018
Est. completion date April 2019

Study information

Verified date June 2018
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
Off-Pump Coronary Artery Bypass (OPCAB) surgery
Off-Pump Coronary Artery Bypass (OPCAB) surgery. This study is retrospective study

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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