Short term effect of vitamin D administrationon the clinical outcomes in patients undergoing valve replacement surgery / Sandra Nael Naguib Wahba ; Supervised Samar F. Farid , Nirmeen A. Sabry , Adel Mohamad Alansary

Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Pharmaceutics

Background: The discovery that most body tissues express vitamin D receptors, has provided new insights to the biological activity of vitamin D. Many recent studies have found a positive association between vitamin D deficiency and worse clinical outcomes in critically-ill patients. Patients undergoing open-heart surgeries are at higher risk due to the associated life-threatening postoperative complications. The suggested beneficial effects of active vitamin D on the cardiovascular system, immune functions, and wound healing could be of particular interest in critically-ill patients, especially those undergoing valve replacement surgery. Objective: This study was conducted to determine and to compare the effect associated with alfacalcidol supplementation versus control on the overall post-cardiac surgery clinical parameters. The primary outcomes were length of stay in intensive care unit and in hospital. Secondary outcomes were the incidence of postoperative hospital acquired infections, cardiac complications, and in-hospital mortality. Methods: This is a randomized, open-label, controlled, single center trial, conducted at the Cardiovascular and Thoracic Academy, Ain Shams University, from April 2017 to January 2018. This study included 89 adult patients undergoing valve replacement surgery who were randomized to the control group (n = 42) or to the intervention group (n = 47) assigned to daily 2 mcg of alfacalcidol started two to four days before operation and continued throughout the hospital stay. Blood samples were withdrawn at the following time points: T1) immediately before alfacalcidol first dose administration (baseline); T2) 48 hours post-surgery; T3) 4 days post-ICU discharge. At each time point, serum levels of 25-hydroxyvitamin D, total calcium, phosphorous, kidney functions, liver functions, hemoglobin, platelet and white blood cells count were assessed. Incidence of postoperative complications were also evaluated daily during the hospital stay. Results: A total of 86 patients were included in the final analysis with 51 (59.3%) patients being vitamin D deficient on hospital admission. Treatment with alfacalcidol resulted in a statistically significant decrease in the intensive care unit length of stay (ICU LOS) (Hazard ratio = 1.61, 95% confidence interval = 1.77{u2013}2.81, P = 0.041) and hospital length of stay (LOS) (Hazard ratio = 1.63, 95% confidence interval = 1.04{u2013}2.55, P= 0.034)

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