Cardiac Valve Replacement Complication
Conditions
Keywords
LOS, mediastinitis, secondary myocardial infection
Brief summary
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.
Detailed description
Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels \< 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty. The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling. The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.
Interventions
2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized ,controlled, open-label, parallel clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing mechanical valve replacement surgery
Exclusion criteria
* combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery * valvular replacement redo * valvular replacement surgery secondary to infective endocarditis * on dialysis * ALT levels 2-3 times higher than normal range * CHD, * impaired gastrointestinal function * indication for vitamin D supplementation within the prior month * hypercalcemia defined as total calcium \>10.4 mg/dl * hyperphosphatemia defined as serum phosphate \> 4.5 mg/dl * pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hospital length of stay | time to hospital discharge, up to 15 days | length of hospital stay in days starting from ICU admission to hospital discharge. |
| intensive-care unite length of stay | time to ICU discharge, up to 7 days | length of hospital stay in hours starting from ICU admission to ICU discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative complications | during hospital stay, up to 15 days | compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms |
| mortality | during hospital stay, up to 15 days | compare mortality rate between the 2 arms |
| monitor alfacalcidol safety | during hospital stay, up tp 15 days | the measurement of alfacalcidol blood concentration indirectly through the measurement of serum 25(OH)D and monitoring of its metabolic effect through the measurement of serum total calcium and phosphorous |
Countries
Egypt
Outcome results
None listed