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

NCT ID: NCT06399627

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 433 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2024-05-31

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.

Conditions

Coronary Artery Bypass, Off-Pump; Iron Deficiencies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Iron replete

Patient who did not meet the criteria for iron deficiency (see below)

No interventions assigned to this group

Iron deficient

patients with preoperative iron profile of either of the following were defined as iron deficient:

1. serum ferritin <100mcg/L

2. 100mcg/L < serum ferritin <300mcg/L and

• transferrin saturation < 20% or
• C reactive protein ≥ 5mg/L

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University Health system, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

seohee Ko

Role: primary

shk0207@yuhs.ac

82-10-9345-6520

Other Identifiers

4-2022-1112

Identifier Type: -

Identifier Source: org_study_id