Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin

Coronary Artery Disease Clinical Trial

Official title:

Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04986033
• Other study ID #: 4-2021-0707
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: July 2021
• Source: Yonsei University
• Contact: Kwang Sub Kim
• Phone: +82-2-2224-1502
• Email: subsub84[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: July 30, 2024
• Est. primary completion date: July 15, 2024
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship about pre-operative vitamin D level and recovery of hemoglobin	Vitamin D is a fat-soluble vitamin, a regulator acting on bone and calcium metabolism, and is known to affect the pathophysiology of several chronic diseases, and is particularly closely related to heart disease.; Vitamin D deficiency was observed in 56% of patients undergoing cardiac surgery, and low vitamin D concentrations increased the risk of postoperative infection and organ failure, atrial fibrillation, and delirium.; It is also known that vitamin D is closely related to anemia by regulating the secretion of erythroferrone and changing the concentration of hepcidin.	Up to 1month