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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfacalcidol | Experimental | Patients allocated to the alfacalcidol group received 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. |
|
| Control | No Intervention | Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfacalcidol 1 MCG Oral Capsule | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| hospital length of stay | length of hospital stay in days starting from ICU admission to hospital discharge. | time to hospital discharge, up to 15 days |
| intensive-care unite length of stay | length of hospital stay in hours starting from ICU admission to ICU discharge. | time to ICU discharge, up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative complications | compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms | during hospital stay, up to 15 days |
| mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El-Demerdash Cardiac Academy Hospital, Ain Shams University | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33339609 | Derived | Naguib SN, Sabry NA, Farid SF, Alansary AM. Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial. Clin Ther. 2021 Jan;43(1):e1-e18. doi: 10.1016/j.clinthera.2020.11.008. Epub 2020 Dec 16. |
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| ID | Term |
|---|---|
| D008480 | Mediastinitis |
| ID | Term |
|---|---|
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C008088 | alfacalcidol |
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randomized ,controlled, open-label, parallel clinical trial
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compare mortality rate between the 2 arms
| during hospital stay, up to 15 days |
| monitor alfacalcidol safety | 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 | during hospital stay, up tp 15 days |