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

NCT06399627 | Recruiting

• 1 other identifier: 4-2022-1112
• Study Type: observational
• Target: 433
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (1)

• Post discharge hemoglobin

  Until 1 year after surgery

Study Arms (2)

Iron replete

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

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

Eligibility Criteria

• Age: 29 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-anemic patients who underwent off pump coronary artery bypass surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health system, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 6, 2024
• Study Start: November 1, 2016
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)