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  • Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled Trial.

    3 July 2018

    BACKGROUND: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of "tight" glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00's, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies. OBJECTIVE: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. METHODS: This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction. RESULTS: The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018. CONCLUSIONS: This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN00550641; http://www.isrctn.com/ISRCTN00550641 (Archived at WebCite: http://www.webcitation.org/6xk8NXxNv).

  • Does bone mineral density improve the predictive accuracy of fracture risk assessment? A prospective cohort study in Northern Denmark.

    27 June 2018

    OBJECTIVE: To evaluate the added predictive accuracy of bone mineral density (BMD) to fracture risk assessment. DESIGN: Prospective cohort study using data between 01 January 2010 and 31 December 2012. SETTING: North Denmark Osteoporosis Clinic of referred patients presenting with at least one fracture risk factor to the referring doctor. PARTICIPANTS: Patients aged 40-90 years; had BMD T-score recorded at the hip and not taking osteoporotic preventing drugs for more than 1 year prior to baseline. MAIN OUTCOME MEASURES: Incident diagnoses of osteoporotic fractures (hip, spine, forearm, humerus and pelvis) were identified using the National Patient Registry of Denmark during 01 January 2012-01 January 2014. Cox regression was used to develop a fracture model based on predictors in the Fracture Risk Assessment Tool (FRAX®), with and without, binary and continuous BMD. Change in Harrell's C-Index and Reclassification tables were used to describe the added statistical value of BMD. RESULTS: Adjusting for predictors included in FRAX®, patients with osteoporosis (T-score ≤-2.5) had 75% higher hazard of a fracture compared with patients with higher BMD (HR: 1.75 (95% CI 1.28 to 2.38)). Forty per cent lower hazard was found per unit increase in continuous BMD T-score (HR: 0.60 (95% CI 0.52 to 0.69)).Accuracy improved marginally, and Harrell's C-Index increased by 1.2% when adding continuous BMD (0.76 to 0.77). Reclassification tables showed continuous BMD shifted 529 patients into different risk categories; 292 of these were reclassified correctly (57%; 95% CI 55% to 64%). Adding binary BMD however no improvement: Harrell's C-Index decreased by 0.6%. CONCLUSIONS: Continuous BMD marginally improves fracture risk assessment. Importantly, this was only found when using continuous BMD measurement for osteoporosis. It is suggested that future focus should be on evaluation of this risk factor using routinely collected data and on the development of more clinically relevant methodology to assess the added value of a new risk factor.