Skip to main content

Table 2 Patient eligibility criteria

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