Køge, Denmark
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Kruse H.,University Hospital Herlev | Kruse H.,Herlev Hospital | Christensen K.P.,University Hospital Herlev | Moller A.M.,University Hospital Herlev | And 2 more authors.
Journal of Clinical Anesthesia | Year: 2015

Study objective Ankle surgery is often done using a tourniquet. Ischemia/reperfusion injury caused by the tourniquet may increase postoperative pain. The study objective was to investigate the amount of opioids given to patients after ankle surgery with and without tourniquet. Design We did a cohort study based on data from patient's records between January 2008 and December 2011. Setting Information is gathered from operating room, postanesthetic care unit, and surgical ward in a university hospital. Patients We identified patients undergoing reconstructive ankle fracture surgery from hospital records. We excluded multiple fractures of the same extremity, major trauma, reoperations, arthrodesis of the ankle joint, and missing data on tourniquet use. We included 603 patients. Interventions For each patient, we registered for how long (minutes) the tourniquet was inflated. Measurements Main outcome was opioid use during first 24 hours postoperatively (in equipotent intravenous morphine doses). Secondary outcomes were the peak pain on a verbal rating scale, time in postanesthetic care unit, and additional antiemetic medicine. We performed multiple regression to analyze the primary outcome. Main results Three hundred fifty-eight patients underwent surgery with tourniquet. There was a correlation between tourniquet time and postoperative opioid use (P value =.001) after controlling for confounders. The slope of the correlation was 0.04 mg/min (95% confidence interval, 0.02-0.07), which means there is an increase in postoperative opioid use by 0.43 mg for every 10 minutes of tourniquet time. Conclusion We found an increase in postoperative opioid consumption correlated to tourniquet use. Possible preventive measures with antioxidant treatment to prevent ischemia/reperfusion injury should be investigated. © 2015 Elsevier Inc. All rights reserved.


Johansen M.E.,Copenhagen University | Jensen J.-U.,Copenhagen University | Bestle M.H.,Nordsjaellands Hospital | Ostrowski S.R.,Rigshospitalet | And 13 more authors.
Thrombosis Research | Year: 2015

Introduction Coagulopathy associates with poor outcome in sepsis. Mild induced hypothermia has been proposed as treatment in sepsis but it is not known whether this intervention worsens functional coagulopathy. Materials and methods Interim analysis data from an ongoing randomized controlled trial; The Cooling And Surviving Septic shock (CASS) study. Patients suffering severe sepsis/septic shock are allocated to either mild induced hypothermia (cooling to 32-34 °C for 24 hours) or control (uncontrolled temperature). Trial registration: NCT01455116. Thrombelastography (TEG) is performed three times during the first day after study enrollment in all patients. Reaction time (R), maximum amplitude (MA) and patients' characteristics are here reported. Results One hundred patients (control n = 50 and intervention n = 50; male n = 59; median age 68 years) with complete TEG during follow-up were included. At enrollment, 3%, 38%, and 59% had a hypocoagulable, normocoagulable, and hypercoagulable TEG clot strength (MA), respectively. In the hypothermia group, functional coagulopathy improved during the hypothermia phase, measured by R and MA, in patients with hypercoagulation as well as in patients with hypocoagulation (correlation between ΔR and initial R: rho = -0.60, p < 0.0001 and correlation between ΔMA and initial MA: rho = -0.50, p = 0.0002). Similar results were not observed in the control group neither for R (rho = -0.03, p = 0.8247) nor MA (rho = -0.15, p = 0.3115). Conclusion Mild induced hypothermia did seem to improve functional coagulopathy in septic patients. This improvement of functional coagulopathy parameters during the hypothermia intervention persisted after rewarming. Randomized trials are warranted to determine whether the positive effect on sepsis-related coagulopathy can be transformed to improved survival. © 2014 Elsevier Ltd. All rights reserved.


Christensen J.,Copenhagen University | Fisker A.,Copenhagen University | Mortensen E.L.,Copenhagen University | Olsen L.R.,Child and Adolescent Mental Health Center | And 3 more authors.
Scandinavian Journal of Public Health | Year: 2015

Purpose: Mental distress is common in persons experiencing low back pain and who are sick-listed or at risk of being sick-listed. It is, however, not known how mental distress measured by the Symptoms Check List-90 differs between patients with low back pain and the general population. The objective of this study was to compare mental symptoms and distress as measured by the Symptoms Check List-90 in sick-listed or at risk of being sick-listed patients with low back pain with a population-based control group. Methods: Mental distress was compared in a group of patients with low back pain (n=770) and a randomly selected population-based reference group (n=909). Established Danish cut-off values for mental distress were used to evaluate the mental distress status in the low back pain and control group and logistic regression was used to calculate odds ratios for the Global Severity Index and the symptom scales of the Symptoms Check List-90 while controlling for baseline demographic differences between the groups. Results: Group mean scores showed that all symptom scales and the Global Severity Index for both sexes were statistically elevated in the low back pain group, except for interpersonal sensitivity in women. When the scores were dichotomized to cases and non-cases of mental distress, a significantly higher prevalence of cases was observed in the low back pain group compared to the reference group on all symptom check list scales, except for paranoid ideation for both sexes and interpersonal sensitivity for women. The biggest between-group difference was observed for the somatization symptom scale. Conclusions: Low back pain patients who are sick-listed or at risk of being sick-listed, are more mentally distressed compared to a randomly selected sample of the general Danish population. Self-reported symptoms of somatization, anxiety, phobic anxiety, obsessive-compulsive, depression and hostility are all more common among patients with low back pain compared to the general population. © Associations of Public Health in the Nordic Countries Regions.


Andersen L.L.,Helmholtz Center Munich | Sundstrup E.,Helmholtz Center Munich | Boysen M.,Helmholtz Center Munich | Due Jakobsen M.,Helmholtz Center Munich | And 2 more authors.
Journal of Medical Internet Research | Year: 2013

Background: Although the hazardous health effects of a sedentary lifestyle are well known, many adults struggle with regular physical activity. Simple and efficient encouragements for increased physical activity are needed. Objective: To determine the effect on cardiovascular health of email-based encouragements to do daily stair-walks at work together with colleagues among adults in sedentary occupations. Methods: A single-blind randomized controlled trial was performed at a large administrative company in Copenhagen, Denmark. Participants were 160 office workers (125 women, 35 men; mean age 42 years, SD 10; sitting 89.5% of work time). At baseline, aerobic fitness was 37 mL/min/kg (SD 9), mean blood pressure was 118/79 mmHg (SD 14/9), and mean body mass index (BMI) was 23 kg/m2 (SD 4). Participants were randomly assigned (2:1 ratio) to an email group receiving weekly email-based encouragements to walk the stairs for 10 minutes a day or to a control group receiving weekly reminders to continue their usual physical activities. The primary outcome was the change from baseline to 10-week follow-up in aerobic fitness determined from a maximal cycle test. The examiner was blinded to group allocation. Results: Adherence to the email encouragements was fairly high with 82.7% of the participants performing at least 3 sessions of 10-minute stair-walks per week (mean 3.3, SD 1.3). Mean heart rate reached 167 beats/min (SD 10) during stair-walks. In the intention-to-treat analysis, aerobic fitness increased 1.45 mL/min/kg (95% CI 0.64-2.27) at 10-week follow-up in the email group compared with the control group. In participants with low aerobic fitness at baseline (n=56), aerobic fitness increased 1.89 mL/min/kg (95% CI 0.53-3.24), and systolic and diastolic blood pressure decreased 4.81 mmHg (95% CI 0.47-9.16) and 2.67 mmHg (95% CI 0.01-5.32), respectively, in the email group compared with the control group. Body weight decreased in the email group of those with low aerobic fitness compared with the control group, but this was not statistically significant. Conclusions: Simple and inexpensive email-based encouragements to do daily stair-walks together with colleagues at work improves cardiovascular health among adults in sedentary occupations. There exists an enormous potential to prevent the hazardous health effects of a sedentary lifestyle through the use of email-based encouragements to do short bouts of physical activity at the workplace.


Lundby-Christensen L.,Steno Diabetes Center | Lundby-Christensen L.,Copenhagen University | Vaag A.,Steno Diabetes Center | Vaag A.,Copenhagen University | And 33 more authors.
BMJ Open | Year: 2016

Objective: To assess the effect of 3 insulin analogue regimens on change in carotid intima-media thickness (IMT) in patients with type 2 diabetes. Design and setting: Investigator-initiated, randomised, placebo-controlled trial with a 2×3 factorial design, conducted at 8 hospitals in Denmark. Participants and interventions: Participants with type 2 diabetes (glycated haemoglobin (HbA1c)≥7.5% (≥58 mmol/mol), body mass index >25 kg/m2) were, in addition to metformin versus placebo, randomised to 18 months open-label biphasic insulin aspart 1-3 times daily (n=137) versus insulin aspart 3 times daily in combination with insulin detemir once daily (n=138) versus insulin detemir alone once daily (n=137), aiming at HbA1c≤7.0% (≤53 mmol/mol). Outcomes: Primary outcome was change in mean carotid IMT (a marker of subclinical cardiovascular disease). HbA1c, insulin dose, weight, and hypoglycaemic and serious adverse events were other prespecified outcomes. Results: Carotid IMT change did not differ between groups (biphasic -0.009 mm (95% CI -0.022 to 0.004), aspart+detemir 0.000 mm (95% CI -0.013 to 0.013), detemir -0.012 mm (95% CI -0.025 to 0.000)). HbA1c was more reduced with biphasic (-1.0% (95% CI -1.2 to -0.8)) compared with the aspart +detemir (-0.4% (95% CI -0.6 to -0.3)) and detemir (-0.3% (95% CI -0.4 to -0.1)) groups (p<0.001). Weight gain was higher in the biphasic (3.3 kg (95% CI 2.7 to 4.0) and aspart+detemir (3.2 kg (95% CI 2.6 to 3.9)) compared with the detemir group (1.9 kg (95% CI 1.3 to 2.6)). Insulin dose was higher with detemir (1.6 IU/kg/day (95% CI 1.4 to 1.8)) compared with biphasic (1.0 IU/kg/day (95% CI 0.9 to 1.1)) and aspart +detemir (1.1 IU/kg/day (95% CI 1.0 to 1.3)) (p<0.001). Number of participants with severe hypoglycaemia and serious adverse events did not differ. Conclusions: Carotid IMT change did not differ between 3 insulin regimens despite differences in HbA1c, weight gain and insulin doses. The trial only reached 46% of planned sample size and lack of power may therefore have affected our results.


Lundby-Christensen L.,Steno Diabetes Center | Lundby-Christensen L.,Copenhagen University | Tarnow L.,Steno Diabetes Center | Tarnow L.,Nordsjaellands University Hospital Hillerod | And 33 more authors.
BMJ Open | Year: 2016

Objective: To assess the effect of metformin versus placebo both in combination with insulin analogue treatment on changes in carotid intima-media thickness (IMT) in patients with type 2 diabetes. Design and setting: Investigator-initiated, randomised, placebo-controlled trial with a 2×3 factorial design conducted at eight hospitals in Denmark. Participants and interventions: 412 participants with type 2 diabetes (glycated haemoglobin (HbA1c) ≥7.5% (≥58 mmol/mol); body mass index >25 kg/m2) were in addition to open-labelled insulin treatment randomly assigned 1:1 to 18 months blinded metformin (1 g twice daily) versus placebo, aiming at an HbA1c ≤7.0% (≤53 mmol/mol). Outcomes: The primary outcome was change in the mean carotid IMT (a marker of subclinical cardiovascular disease). HbA1c, insulin dose, weight and hypoglycaemic and serious adverse events were other prespecified outcomes. Results: Change in the mean carotid IMT did not differ significantly between the groups (betweengroup difference 0.012 mm (95% CI -0.003 to 0.026), p=0.11). HbA1c was more reduced in the metformin group (between-group difference.0.42% (95% CI.0.62% to.0.23%), p<0.001)), despite the significantly lower insulin dose at end of trial in the metformin group (1.04 IU/kg (95% CI 0.94 to 1.15)) compared with placebo (1.36 IU/kg (95% CI 1.23 to 1.51), p<0.001). The metformin group gained less weight (between-group difference -2.6 kg (95% CI -3.3 to -1.8), p<0.001). The groups did not differ with regard to number of patients with severe or non-severe hypoglycaemic or other serious adverse events, but the metformin group had more nonsevere hypoglycaemic episodes (4347 vs 3161, p<0.001). Conclusions: Metformin in combination with insulin did not reduce carotid IMT despite larger reduction in HbA1c, less weight gain, and smaller insulin dose compared with placebo plus insulin. However, the trial only reached 46% of the planned sample size and lack of power may therefore have affected our results.


PubMed | University of Aarhus, Steno Diabetes Center, Copenhagen University, Novo Nordisk AS and 2 more.
Type: Comparative Study | Journal: BMJ open | Year: 2016

To assess the effect of metformin versus placebo both in combination with insulin analogue treatment on changes in carotid intima-media thickness (IMT) in patients with type 2 diabetes.Investigator-initiated, randomised, placebo-controlled trial with a 2 3 factorial design conducted at eight hospitals in Denmark.412 participants with type 2 diabetes (glycated haemoglobin (HbA1c) 7.5% ( 58 mmol/mol); body mass index >25 kg/m2) were in addition to open-labelled insulin treatment randomly assigned 1:1 to 18 months blinded metformin (1 g twice daily) versus placebo, aiming at an HbA1c 7.0% ( 53 mmol/mol).The primary outcome was change in the mean carotid IMT (a marker of subclinical cardiovascular disease). HbA1c, insulin dose, weight and hypoglycaemic and serious adverse events were other prespecified outcomes.Change in the mean carotid IMT did not differ significantly between the groups (between-group difference 0.012 mm (95% CI -0.003 to 0.026), p=0.11). HbA1c was more reduced in the metformin group (between-group difference -0.42% (95% CI -0.62% to -0.23%), p<0.001)), despite the significantly lower insulin dose at end of trial in the metformin group (1.04 IU/kg (95% CI 0.94 to 1.15)) compared with placebo (1.36 IU/kg (95% CI 1.23 to 1.51), p<0.001). The metformin group gained less weight (between-group difference -2.6 kg (95% CI -3.3 to -1.8), p<0.001). The groups did not differ with regard to number of patients with severe or non-severe hypoglycaemic or other serious adverse events, but the metformin group had more non-severe hypoglycaemic episodes (4347 vs 3161, p<0.001).Metformin in combination with insulin did not reduce carotid IMT despite larger reduction in HbA1c, less weight gain, and smaller insulin dose compared with placebo plus insulin. However, the trial only reached 46% of the planned sample size and lack of power may therefore have affected our results.NCT00657943; Results.


PubMed | University of Aarhus, Steno Diabetes Center, Copenhagen University, Novo Nordisk AS and 2 more.
Type: Journal Article | Journal: BMJ open | Year: 2016

To assess the effect of 3 insulin analogue regimens on change in carotid intima-media thickness (IMT) in patients with type 2 diabetes.Investigator-initiated, randomised, placebo-controlled trial with a 2 3 factorial design, conducted at 8 hospitals in Denmark.Participants with type 2 diabetes (glycated haemoglobin (HbA1c) 7.5% ( 58 mmol/mol), body mass index >25 kg/m(2)) were, in addition to metformin versus placebo, randomised to 18 months open-label biphasic insulin aspart 1-3 times daily (n=137) versus insulin aspart 3 times daily in combination with insulin detemir once daily (n=138) versus insulin detemir alone once daily (n=137), aiming at HbA1c 7.0% ( 53 mmol/mol).Primary outcome was change in mean carotid IMT (a marker of subclinical cardiovascular disease). HbA1c, insulin dose, weight, and hypoglycaemic and serious adverse events were other prespecified outcomes.Carotid IMT change did not differ between groups (biphasic -0.009 mm (95% CI -0.022 to 0.004), aspart+detemir 0.000 mm (95% CI -0.013 to 0.013), detemir -0.012 mm (95% CI -0.025 to 0.000)). HbA1c was more reduced with biphasic (-1.0% (95% CI -1.2 to -0.8)) compared with the aspart+detemir (-0.4% (95% CI -0.6 to -0.3)) and detemir (-0.3% (95% CI -0.4 to -0.1)) groups (p<0.001). Weight gain was higher in the biphasic (3.3 kg (95% CI 2.7 to 4.0) and aspart+detemir (3.2 kg (95% CI 2.6 to 3.9)) compared with the detemir group (1.9 kg (95% CI 1.3 to 2.6)). Insulin dose was higher with detemir (1.6 IU/kg/day (95% CI 1.4 to 1.8)) compared with biphasic (1.0 IU/kg/day (95% CI 0.9 to 1.1)) and aspart+detemir (1.1IU/kg/day (95% CI 1.0 to 1.3)) (p<0.001). Number of participants with severe hypoglycaemia and serious adverse events did not differ.Carotid IMT change did not differ between 3 insulin regimens despite differences in HbA1c, weight gain and insulin doses. The trial only reached 46% of planned sample size and lack of power may therefore have affected our results.NCT00657943.

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