clinicaltrials.gov Identifier: NCT01130181.
IntroductionVitamin D deficiency is encountered frequently in critically ill patients and might be harmful. Current nutrition guidelines recommend very low vitamin D doses. The objective of this trial was to evaluate the safety and efficacy of a single oral high-dose vitamin D3 supplementation in an intensive care setting over a one-week observation period.MethodsThis was a randomized, double-blind, placebo-controlled pilot study in a medical ICU at a tertiary care university center in Graz, Austria. Twenty-five patients (mean age 62 ± 16yrs) with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤20 ng/ml] and an expected stay in the ICU >48 hours were included and randomly received either 540,000 IU (corresponding to 13.5 mg) of cholecalciferol (VITD) dissolved in 45 ml herbal oil or matched placebo (PBO) orally or via feeding tube.ResultsThe mean serum 25(OH)D increase in the intervention group was 25 ng/ml (range 1-47 ng/ml). The highest 25(OH)D level reached was 64 ng/ml, while two patients showed a small (7 ng/ml) or no response (1 ng/ml). Hypercalcemia or hypercalciuria did not occur in any patient. From day 0 to day 7, total serum calcium levels increased by 0.10 (PBO) and 0.15 mmol/L (VITD; P < 0.05 for both), while ionized calcium levels increased by 0.11 (PBO) and 0.05 mmol/L (VITD; P < 0.05 for both). Parathyroid hormone levels decreased by 19 and 28 pg/ml (PBO and VITD, ns) over the seven days, while 1,25(OH)D showed a transient significant increase in the VITD group only.ConclusionsThis pilot study shows that a single oral ultra-high dose of cholecalciferol corrects vitamin D deficiency within 2 days in most patients without causing adverse effects like hypercalcemia or hypercalciuria. Further research is needed to confirm our results and establish whether vitamin D supplementation can affect the clinical outcome of vitamin D deficient critically ill patients.EudraCT Number2009-012080-34German Clinical Trials Register (DRKS)DRKS00000750
IntroductionVitamin D plays a key role in immune function. Deficiency may aggravate the incidence and outcome of infectious complications in critically ill patients. We aimed to evaluate the prevalence of vitamin D deficiency and the correlation between serum 25-hydroxyvitamin D (25(OH) D) and hospital mortality, sepsis mortality and blood culture positivity.MethodsIn a single-center retrospective observational study at a tertiary care center in Graz, Austria, 655 surgical and nonsurgical critically ill patients with available 25(OH) D levels hospitalized between September 2008 and May 2010 were included. Cox regression analysis adjusted for age, gender, severity of illness, renal function and inflammatory status was performed. Vitamin D levels were categorized by month-specific tertiles (high, intermediate, low) to reflect seasonal variation of serum 25(OH) D levels.ResultsOverall, the majority of patients were vitamin D deficient (<20 ng/ml; 60.2%) or insufficient (≥20 and <30 ng/dl; 26.3%), with normal 25(OH) D levels (>30 ng/ml) present in only 13.6%. The prevalence of vitamin D deficiency and mean 25(OH) D levels was significantly different in winter compared to summer months (P <0.001). Hospital mortality was 20.6% (135 of 655 patients). Adjusted hospital mortality was significantly higher in patients in the low (hazard ratio (HR) 2.05, 95% confidence interval (CI) 1.31 to 3.22) and intermediate (HR 1.92, 95% CI 1.21 to 3.06) compared to the high tertile. Sepsis was identified as cause of death in 20 of 135 deceased patients (14.8%). There was no significant association between 25(OH) D and C-reactive protein (CRP), leukocyte count or procalcitonin levels. In a subgroup analysis (n = 244), blood culture positivity rates did not differ between tertiles (23.1% versus 28.2% versus 17.1%, P = 0.361).ConclusionsLow 25(OH) D status is significantly associated with mortality in the critically ill. Intervention studies are needed to investigate the effect of vitamin D substitution on mortality and sepsis rates in this population.
Background: This study investigated the efficacy, safety, and usability of standardized glycemic management by a computerized decision support system for non-critically ill hospitalized patients with type 2 diabetes on four different wards.Materials and Methods: In this open, noncontrolled intervention study, glycemic management of 99 patients with type 2 diabetes (62% acute admissions; 41 females; age, 67±11 years; hemoglobin A1c, 65±21 mmol/mol; body mass index, 30.4±6.5 kg/m2) on clinical wards (Cardiology, Endocrinology, Nephrology, Plastic Surgery) of a tertiary-care hospital was guided by GlucoTab® (Joanneum Research GmbH [Graz, Austria] and Medical University of Graz [Graz, Austria]), a mobile decision support system providing automated workflow support and suggestions for insulin dosing to nurses and physicians.Results: Adherence to insulin dosing suggestions was high (96.5% bolus, 96.7% basal). The primary outcome measure, percentage of blood glucose (BG) measurements in the range of 70–140 mg/dL, occurred in 50.2±22.2% of all measurements. The overall mean BG level was 154±35 mg/dL. BG measurements in the ranges of 60–70 mg/dL, 40–60 mg/dL, and <40 mg/dL occurred in 1.4%, 0.5%, and 0.0% of all measurements, respectively. A regression analysis showed that acute admission to the Cardiology Ward (+30 mg/dL) and preexisting home insulin therapy (+26 mg/dL) had the strongest impact on mean BG. Acute admission to other wards had minor effects (+4 mg/dL). Ninety-one percent of the healthcare professionals felt confident with GlucoTab, and 89% believed in its practicality and 80% in its ability to prevent medication errors.Conclusions: An efficacious, safe, and user-accepted implementation of GlucoTab was demonstrated. However, for optimized personalized patient care, further algorithm modifications are required.
FGF23 is a bone-derived phosphaturic hormone that may become a useful biomarker for the identification of high-risk patients in chronic but also acute disease. It rises early in chronic kidney disease and is strongly and independently associated with excess morbidity and mortality. Emerging data suggest that FGF23 is also elevated in different scenarios of acute illness. In this review, we give an overview on the role of this interesting disease marker and potential and proven interventional strategies and discuss a blueprint for future research.
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