Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial |
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| Authors: | Sandra N. Naguib Nirmeen A. Sabry Samar F. Farid Adel Mohamad Alansary |
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| Affiliation: | 1. Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt;2. Department of Anesthesiology and Critical Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt;1. NYU Langone Health, Department of Medicine, New York, NY, USA;2. Pfizer Inc, New York, NY, USA;1. Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China;2. Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China |
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| Abstract: | PurposeVitamin D deficiency is highly prevalent in critically ill patients, and has been associated with more prolonged length of hospital stay and poor prognosis. Patients undergoing open-heart surgery are at higher risk due to the associated life-threatening postoperative complications. This study investigated the effect of alfacalcidol treatment on the length of hospital stay in patients undergoing valve-replacement surgery.MethodsThis single-center, randomized, open-label, controlled trial was conducted at El-Demerdash Cardiac Academy Hospital (Cairo, Egypt), from April 2017 to January 2018. This study included adult patients undergoing valve-replacement surgery who were randomized to the intervention group (n = 47; alfacalcidol 2 μg/d started 48 h before surgery and continued throughout the hospital stay) or to the control group (n = 42). The primary end points were lengths of stay (LOS) in the intensive care unit (ICU) and in the hospital. Secondary end points were the prevalence of postoperative hospital-acquired infections, cardiac complications, and in-hospital mortality.FindingsA total of 86 patients were included in the final analysis, with 51 (59.3%) being vitamin D deficient on hospital admission. Treatment with alfacalcidol was associated with a statistically significant decrease in ICU LOS (hazard ratio = 1.61; 95% CI, 1.77–2.81; P = 0.041) and hospital LOS (hazard ratio = 1.63; 95% CI, 1.04–2.55; P = 0.034). Treated patients had a significantly lower postoperative infection rate than did the control group (35.5% vs 56.1%; P = 0.017). The median epinephrine dose was lower in the intervention group compared to that in the control group (5.9 vs 8.2 mg; P = 0.019). The rate of in-hospital mortality was not significantly different between the 2 groups.ImplicationsEarly treatment with 2 μg of alfacalcidol in patients undergoing valve-replacement surgery is promising and well tolerated. This effect may be attributed to its immunomodulatory and cardioprotective mechanisms. ClinicalTrials.gov identifier: NCT04085770. |
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| Keywords: | alfacalcidol critical care hospitalacquired infection length of stay valve-replacement surgery vitamin D |
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