ICE COLD ERIC – International collaborative effort on chronic obstructive lung disease: exacerbation risk index cohorts – Study protocol for an international COPD cohort study

<p>Abstract</p> <p>Background</p> <p>Chronic Obstructive Pulmonary Disease (COPD) is a systemic disease; morbidity and mortality due to COPD are on the increase, and it has great impact on patients' lives. Most COPD patients are managed by general practitioners (GP). Too often, GPs base their initial assessment of patient's disease severity mainly on lung function. However, lung function correlates poorly with COPD-specific health-related quality of life and exacerbation frequency. A validated COPD disease risk index that better represents the clinical manifestations of COPD and is feasible in primary care seems to be useful. The objective of this study is to develop and validate a practical COPD disease risk index that predicts the clinical course of COPD in primary care patients with GOLD stages 2–4.</p> <p>Methods/Design</p> <p>We will conduct 2 linked prospective cohort studies with COPD patients from GPs in Switzerland and the Netherlands. We will perform a baseline assessment including detailed patient history, questionnaires, lung function, history of exacerbations, measurement of exercise capacity and blood sampling. During the follow-up of at least 2 years, we will update the patients' profile by registering exacerbations, health-related quality of life and any changes in the use of medication. The primary outcome will be health-related quality of life. Secondary outcomes will be exacerbation frequency and mortality. Using multivariable regression analysis, we will identify the best combination of variables predicting these outcomes over one and two years and, depending on funding, even more years.</p> <p>Discussion</p> <p>Despite the diversity of clinical manifestations and available treatments, assessment and management today do not reflect the multifaceted character of the disease. This is in contrast to preventive cardiology where, nowadays, the treatment in primary care is based on patient-specific and fairly refined cardiovascular risk profile corresponding to differences in prognosis. After completion of this study, we will have a practical COPD-disease risk index that predicts the clinical course of COPD in primary care patients with GOLD stages 2–4. In a second step we will incorporate evidence-based treatment effects into this model, such that the instrument may guide physicians in selecting treatment based on the individual patients' prognosis.</p> <p>Trial registration</p> <p>ClinicalTrials.gov Archive NCT00706602</p

Is the prevalence of exercise-associated hyponatremia higher in female than in male 100-KM ultra-marathoners?

Purpose. The prevalence of exercise-associated hyponatremia (EAH) has mainly been investigated in male endurance athletes. The aim of the present study was to investigate the prevalence of EAH in female 100-km ultra-marathoners and to compare them to male ultra-runners since females are considered more at risk of EAH. Methods. Changes in body mass, hematocrit, [Na+] and [K+] levels in both plasma and urine, plasma volume, urine specific gravity, and the intake of energy, fluids and electrolytes was determined in 24 male and 19 female 100-km ultra-marathoners. Results. Three male (11%) and one female (5%) ultra-marathoners developed asymptomatic EAH. Body mass decreased, while plasma [Na+], plasma [K+] and hematocrit remained stable in either gender. Plasma volume, urine specific gravity and the potassium-to-sodium ratio in urine increased in either gender. In males, fluid intake was related to running speed (r = 0.50, p = 0.0081), but not to the change in body mass, in post-race plasma [Na+], in the change in hematocrit and in the change in plasma volume. Also in males, the change in hematocrit was related to both the change in plasma [Na+] (r = 0.45, p = 0.0187) and the change in the potassium-to-sodium ratio in urine (r = 0.39, p = 0.044). Sodium intake was neither related to post-race plasma [Na+] nor to the change in plasma volume. Conclusions. The prevalence of EAH was not higher in female compared to male 100-km ultra-marathoners. Plasma volume and plasma [Na+] were maintained and not related to fluid intake, most probably due to an activation of the reninangiotensin-aldosterone-system