Iron Deficiencies Clinical Trial
Official title:
Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
| NCT number | NCT06399627 |
| Other study ID # | 4-2022-1112 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2016 |
| Est. completion date | May 31, 2024 |
| Verified date | April 2024 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 433 |
| Est. completion date | May 31, 2024 |
| Est. primary completion date | May 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 29 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Yonsei University Health system, Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium | 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. | from the end of surgery until patient discharge (assessed up to day 60) | |
| Primary | Number of participants with acute kidney injury | 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. | until 7 days after surgery | |
| Primary | Number of participants with post operative myocardial infarction | 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. | until 48 hours post-surgery | |
| Secondary | Post discharge hemoglobin | Data of hemoglobin levels after discharge until 1 year after surgery was collected to evaluate hemoglobin recovery to preoperative baseline levels. | Until 1 year after surgery |