The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial.

BACKGROUND: Postoperative delirium occurs frequently in elderly hip fracture surgery patients and is associated with poorer overall outcomes. Because xenon anaesthesia has neuroprotective properties, we evaluated its effect on the incidence of delirium and other outcomes after hip fracture surgery. METHODS: This was a phase II, multicentre, randomized, double-blind, parallel-group, controlled clinical trial conducted in hospitals in six European countries (September 2010 to October 2014). Elderly (≥75yr-old) and mentally functional hip fracture patients were randomly assigned 1:1 to receive either xenon- or sevoflurane-based general anaesthesia during surgery. The primary outcome was postoperative delirium diagnosed through postoperative day 4. Secondary outcomes were delirium diagnosed anytime after surgery, postoperative sequential organ failure assessment (SOFA) scores, and adverse events (AEs). RESULTS: Of 256 enrolled patients, 124 were treated with xenon and 132 with sevoflurane. The incidence of delirium with xenon (9.7% [95% CI: 4.5 -14.9]) or with sevoflurane (13.6% [95% CI: 7.8 -19.5]) were not significantly different (P=0.33). Overall SOFA scores were significantly lower with xenon (least-squares mean difference: -0.33 [95% CI: -0.60 to -0.06]; P=0.017). For xenon and sevoflurane, the incidence of serious AEs and fatal AEs was 8.0% vs 15.9% (P=0.05) and 0% vs 3.8% (P=0.06), respectively. CONCLUSIONS: Xenon anaesthesia did not significantly reduce the incidence of postoperative delirium after hip fracture surgery. Nevertheless, exploratory observations concerning postoperative SOFA-scores, serious AEs, and deaths warrant further study of the potential benefits of xenon anaesthesia in elderly hip fracture surgery patients. CLINICAL TRIAL REGISTRATION: EudraCT 2009-017153-35; ClinicalTrials.gov NCT01199276.

Evaluation of the Mobil-O-Graph new generation ABPM device using the ESH criteria.

We report on the validation of the new generation Mobil-O-Graph 24/48 h ambulatory blood pressure monitor according to the criteria of the European Society of Hypertension. In 15 individuals participating in phase I for systolic pressure, all 45 measures differed less than 15 mmHg, 43 and 33 out of 45 differed less than 10 and 5 mmHg. As for diastolic pressures even better scores were reached when the device passed the EHS score. In phase II, data were collected in an additional 18 individuals leaving a total of 33 individuals and 99 measures. The phase counts the achieved percentages of two or three measures per individual within 15, 10 and 5 mmHg limits. Systolic pressures exceeded the required 95, 80 and 65% for 15, 10 and 5 mmHg differences with values of 98, 94 and 71%, respectively. As again for diastolic pressure the values were even better, the device passed phase II also. Thus, all phases of the European Society of Hypertension procedure were passed and the results of this study can recommend the use of the Mobil-O-Graph new generation ambulatory blood pressure monitor device in clinical practice.

Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period.

OBJECTIVE: To compare the effects of a 12-week treatment with 17ss-estradiol given alone and in sequential combination with 3.75 mg of nomegestrol acetate (Naemis), or a placebo on biochemical markers of bone turnover in menopausal women. PATIENTS AND METHODS: A double-blind, randomized, placebo and estradiol-controlled multicenter study was conducted. A total of 176 patients who had been menopausal for 1-10 years, hysterectomized or not, having no contraindications to hormone replacement therapy, without any risks factors for osteoporosis, received one of these treatments during 12 weeks: placebo, 1.5 mg estradiol (E(2)) or 1.5 mg E(2)/3.75 mg nomegestrol acetate (E(2)/NOMAC). The primary efficacy variables were the change in bone markers (total alkaline phosphatase, bone alkaline phosphatase and osteocalcin; urinary type-I collagen peptides). RESULTS: The four biochemical markers decreased only in the E(2)/NOMAC group. Bone alkaline phosphatase, osteocalcin and urinary type-I collagen peptides decreased in the E(2) group. For both active treatment groups compared to the placebo group, the changes were statistically significant after a 12-week treatment. There were no statistically significant differences between the E(2) and the E(2)/NOMAC groups except for total serum alkaline phosphatase, whose mean value decreased in the E(2)/NOMAC group but increased slightly in the E(2) group (p < 0.001). Furthermore, after a 6-week treatment, the changes in biochemical markers of bone turnover were similar to those found after 12 weeks. Safety data were satisfactory with regard to estradiol given alone or in combination with nomegestrol acetate. CONCLUSION: These results demonstrated that 1.5 mg E(2) is effective in reducing bone turnover in postmenopausal women and proved that the combination of 1.5 mg E(2) and 3.75 mg nomegestrol acetate has no deleterious effect on bone remodelling.

The association between chronic diseases and fatigue in the working population.

OBJECTIVE: The aims of this study were to examine (a) whether employees with a chronic disease report more fatigue than employees without a chronic disease, (b) whether number or type of chronic disease is related to fatigue, and (c) whether differences in fatigue level in various types of chronic diseases are related to psychological distress. METHODS: Data were taken from 12,137 employees. Fatigue was measured with the Checklist Individual Strength (CIS). RESULTS: Employees with a chronic disease reported more fatigue (OR=2.9, 95% CI=2.7-3.2). Small differences were observed in the level of fatigue in various types of diseases. A strong linear association between the number of chronic diseases and fatigue was found. Psychological distress explained the higher level of fatigue in some chronic diseases (gastrointestinal diseases and migraine). CONCLUSIONS: Fatigue is more common in employees with a chronic disease. A strong association between number of chronic diseases and fatigue exists. Fatigue in employees with a chronic disease can partly be explained by psychological distress. Some chronic diseases show a stronger association between psychological distress and fatigue.