Clinical trial NCT04986033: Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin
Official title: Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who consented to study enrollment among patients scheduled for off-pump coronary artery bypass graft

Brief summary: Preoperative anemia is present in more than 50% of patients undergoing cardiac surgery, which is associated with increased risk of transfusion, increased length of stay in the intensive care unit, and increased incidence of renal failure and mortality.

To date, clinical research on perioperative anemia has been focused on finding and treating other underlying causes of anemia, lowering the threshold for transfusion, and performing careful transfusion.

However, recently, it was known that hepcidin and erythroferrone are related to iron metabolism and absorption, vitamin D has an inverse correlation with the development of anemia, and is related to hepcidin concentration control.

Therefore, in this study, the relationship between vitamin D, hepcidin concentration and perioperative hemoglobin level in patients with off-pump coronary artery bypass graft surgery was investigated together.


Eligibility criteria: Inclusion Criteria:

1. Patients over 20 years of age undergoing off-pump coronary artery bypass graft

Exclusion Criteria:

1. Emergency operation
2. Minimal invasive coronary artery bypass graft
3. Cooperative operation with other surgery
4. Patients who need a mechanical ventricular assist device
5. Patients with chronic kidney disease (eGFR \< 30)
6. Patients who have a end stage renal disease and need a hemodialysis
7. Patients with a low hemoglobin (Hb \< 10) before surgery
8. Patients who have a some disease(leukemia, myeloma, aplastic anemia, sickle cell anemia, etc) affecting hematopoiesis
9. Patients with a liver cirrhosis
10. Patients who receive vit. D, iron supplements, erythropoietin within 6 months
11. Patients who cannot understand the informed consent (eg. Foreigner, patients with cognitive dysfunction, etc)
12. Patients who disagree this study

Primary outcomes:
measure: Relationship about pre-operative vitamin D level and recovery of hemoglobin
timeFrame: Up to 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
Study officials:
affiliation: Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
name: Kwang Sub Kim
role: PRINCIPAL_INVESTIGATOR
References: