From: Vitamin D for prevention of sternotomy healing complications: REINFORCE-D trial
Inclusion criteria | Exclusion criteria |
---|---|
Patient: | Patient: |
• Undergoing cardiac surgery with sternotomy | • With known hyperparathyroidism |
• With baseline calcium, phosphate, and alkaline phosphatase values in physiological ranges | • Treated or supplemented by vitamin D or its derivatives (alfacalcifediol, calcitriol, paricalcitol) including ergocalciferol (vitamin D2) when used regularly for 3 months before entering the trial |
• With sufficient ability to understand and cooperate in planned medical examinations | • Undergoing repeated sternotomy |
• Czech or Slovak speaker with permanent residence and citizenship in the Czech Republic | • With chronic renal insufficiency associated with osteodystrophy (hyperphosphatemia, hypocalcemia) |
• With initial calcidiol levels less than 75 nmol/L | • With severe hepatic impairment associated with cirrhosis, Child-Pugh score B and C |
• With signed informed consent to enter the trial | • With known metabolic bone disease |
• Male or female between 18 and 95 years of age | • With cancer associated with primary or secondary risk of bone damage |
• With known immunodeficiency | |
• With short bowel syndrome or other malabsorption syndrome that limits absorption of lipophilic vitamins | |
• With long-term cardioactive glycoside and/or thiazide diuretic treatment that cannot be replaced with alternative treatment during cardiac surgery hospitalization | |
• Prior to the planned radiotherapy affecting the body skeleton | |
• With known allergic reaction or intolerance to IMP | |
• With long-term teriparatide treatment or other parathyroid hormone | |
• With long-term bile acid sequestrant treatment which cannot be replaced by any other treatment during cardiac surgery hospitalization | |
• With long-term corticosteroid treatment or other immunosuppressive drugs | |
• With another medical condition which the investigator considers a risk for the patient during the trial | |
• In custody or imprisonment or receiving healthcare without their consent for the purpose of protecting the public interest or protecting the life and health of the individual by law | |
• Pregnant, nursing, or planning to become pregnant during the trial | |
• Participating in another clinical trial |