Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization

Recruiting

• Conditions: Iron Deficiencies; Coronary Artery Bypass, Off-Pump

• Registration Number: NCT06399627
• Lead Sponsor: Yonsei University

Brief Summary

This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11\~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. These two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes.

The primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. Occurrence of any one of these outcomes counted as primary end point met. Secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 433

Inclusion Criteria

• Patients who received off pump coronary artery bypass surgery (OPCAB) between 2016.11.01-2023.05.31

Exclusion Criteria

• preoperative anemia (male Hb <13g/dL, female Hb<12g/dL)
• emergency surgery
• redo-off pump coronary artery bypass surgery
• minimally invasive coronary artery bypass surgery
• OPCAB in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta)
• intraoperative on pump conversion
• lack of sufficient preoperative data (ferritin, transferrin saturation, C-reactive protein) to determine iron status
• administration of intravenous iron within 4 weeks or parenteral iron of more than 2 weeks prior to surgery
• enrollemnt in other clinical studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium	from the end of surgery until patient discharge (assessed up to day 60)	This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Number of participants with acute kidney injury	until 7 days after surgery	This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Number of participants with post operative myocardial infarction	until 48 hours post-surgery	This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.

Secondary Outcome Measures

Name	Time	Method
Post discharge hemoglobin	Until 1 year after surgery	Data of hemoglobin levels after discharge until 1 year after surgery was collected to evaluate hemoglobin recovery to preoperative baseline levels.

Trial Locations

Locations (1)

Yonsei University Health system, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of