Clinical trial NCT04085770: Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
Official title: Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Valve Replacement Complication
Keywords: LOS
mediastinitis
secondary myocardial infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized ,controlled, open-label, parallel clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: hospital length of stay
timeFrame: time to hospital discharge, up to 15 days
measure: intensive-care unite length of stay
timeFrame: time to ICU discharge, up to 7 days
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: during hospital stay, up to 15 days
measure: mortality
timeFrame: during hospital stay, up to 15 days
measure: monitor alfacalcidol safety
timeFrame: during hospital stay, up tp 15 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El-Demerdash Cardiac Academy Hospital, Ain Shams University
Study officials:
References:
citation: 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.