El-Demerdash Cardiac Academy Hospital, Ain Shams University
Cairo, 11562, Egypt
NCT Number: NCT04085770
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Cairo, 11562, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Bone care
Time frame: time to hospital discharge, up to 15 days
length of hospital stay in days starting from ICU admission to hospital discharge.
Time frame: time to ICU discharge, up to 7 days
length of hospital stay in hours starting from ICU admission to ICU discharge.
Time frame: during hospital stay, up to 15 days
compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms
Time frame: during hospital stay, up to 15 days
compare mortality rate between the 2 arms
Time frame: 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
Cairo University
Other
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