Bodil Steen Rasmussen

Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock

BACKGROUND Blood transfusions are frequently given to patients with septic shock. However, the benefits and harms of different hemoglobin thresholds for transfusion have not been established. METHODS In this multicenter, parallel-group trial, we randomly assigned patients in the intensive care unit (ICU) who had septic shock and a hemoglobin concentration of 9 g per deciliter or less to receive 1 unit of leukoreduced red cells when the hemoglobin level was 7 g per deciliter or less (lower threshold) or when the level was 9 g per deciliter or less (higher threshold) during the ICU stay. The primary outcome measure was death by 90 days after randomization. RESULTS We analyzed data from 998 of 1005 patients (99.3%) who underwent randomization. The two intervention groups had similar baseline characteristics. In the ICU, the lower-threshold group received a median of 1 unit of blood (interquartile range, 0 to 3) and the higher-threshold group received a median of 4 units (interquartile range, 2 to 7). At 90 days after randomization, 216 of 502 patients (43.0%) assigned to the lower-threshold group, as compared with 223 of 496 (45.0%) assigned to the higher-threshold group, had died (relative risk, 0.94; 95% confidence interval, 0.78 to 1.09; P=0.44). The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per-protocol populations. The numbers of patients who had ischemic events, who had severe adverse reactions, and who required life support were similar in the two intervention groups. CONCLUSIONS Among patients with septic shock, mortality at 90 days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold; the latter group received fewer transfusions. (Funded by the Danish Strategic Research Council and others; TRISS ClinicalTrials.gov number, NCT01485315.).

On-Pump Versus Off-Pump Coronary Artery Bypass Surgery in Elderly Patients Results From the Danish On-Pump Versus Off-Pump Randomization Study

Background— Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially in elderly patients. Methods and Results— In a multicenter, randomized trial, we assigned 900 patients >70 years of age to conventional coronary artery bypass grafting or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined end point of death, stroke, or myocardial infarction had occurred. At baseline and 6 months postoperatively, self-assessed quality of life was measured with the Medical Outcomes Study Short Form-36 and EuroQol-5D questionnaires. A 6-month follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined end point within 30 days was 10.2% for conventional coronary artery bypass grafting and 10.7% for OPCAB. Implied risk difference of 0.4% (with a 95% confidence interval, −3.6 to 4.4) showed nonsignificance in a standard test for equality (P=0.83) and for noninferiority with an inferiority margin of 0.5% (P=0.49). At the 6-month follow-up, mortality was 4.7% compared with 4.2% (P=0.75). Both groups showed significant improvement in self-assessed health-related quality of life. Conclusions— Both conventional coronary artery bypass grafting and OPCAB are safe procedures that improved the quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However, the noninferiority of OPCAB with the prespecified margin could not be confirmed. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00123981.Background— Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially in elderly patients. Methods and Results— In a multicenter, randomized trial, we assigned 900 patients >70 years of age to conventional coronary artery bypass grafting or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined end point of death, stroke, or myocardial infarction had occurred. At baseline and 6 months postoperatively, self-assessed quality of life was measured with the Medical Outcomes Study Short Form-36 and EuroQol-5D questionnaires. A 6-month follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined end point within 30 days was 10.2% for conventional coronary artery bypass grafting and 10.7% for OPCAB. Implied risk difference of 0.4% (with a 95% confidence interval, −3.6 to 4.4) showed nonsignificance in a standard test for equality ( P =0.83) and for noninferiority with an inferiority margin of 0.5% ( P =0.49). At the 6-month follow-up, mortality was 4.7% compared with 4.2% ( P =0.75). Both groups showed significant improvement in self-assessed health-related quality of life. Conclusions— Both conventional coronary artery bypass grafting and OPCAB are safe procedures that improved the quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However, the noninferiority of OPCAB with the prespecified margin could not be confirmed. Clinical Trial Registration— URL: . Unique identifier: [NCT00123981][1]. # Clinical Perspective {#article-title-28} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00123981&atom=%2Fcirculationaha%2F125%2F20%2F2431.atom

Return to Work in Out-of-Hospital Cardiac Arrest Survivors: A Nationwide Register-Based Follow-Up Study

Background— Data on long-term function of out-of-hospital cardiac arrest survivors are sparse. We examined return to work as a proxy of preserved function without major neurologic deficits in survivors. Methods and Results— In Denmark, out-of-hospital cardiac arrests have been systematically reported to the Danish Cardiac Arrest Register since 2001. During 2001–2011, we identified 4354 patients employed before arrest among 12 332 working-age patients (18–65 years), of whom 796 survived to day 30. Among 796 survivors (median age, 53 years [quartile 1–3, 46–59 years]; 81.5% men), 610 (76.6%) returned to work in a median time of 4 months [quartile 1–3, 1–19 months], with a median time of 3 years spent back at work. A total of 74.6% (N=455) remained employed without using sick leave during the first 6 months after returning to work. This latter proportion of survivors returning to work increased over time (66.1% in 2001–2005 versus 78.1% in 2006–2011; P=0.002). In multivariable Cox regression analysis, factors associated with return to work with ≥6 months of sustainable employment were as follows: (1) arrest during 2006–2011 versus 2001–2005, hazard ratio (HR), 1.38 (95% CI, 1.05–1.82); (2) male sex, HR, 1.48 (95% CI, 1.06–2.07); (3) age of 18 to 49 versus 50 to 65 years, HR, 1.32 (95% CI, 1.02–1.68); (4) bystander-witnessed arrest, HR, 1.79 (95% CI, 1.17–2.76); and (5) bystander cardiopulmonary resuscitation, HR, 1.38 (95% CI, 1.02–1.87). Conclusions— Of 30-day survivors employed before arrest, 76.6% returned to work. The percentage of survivors returning to work increased significantly, along with improved survival during 2001–2011, suggesting an increase in the proportion of survivors with preserved function over time.Background— Data on long-term function of out-of-hospital cardiac arrest survivors are sparse. We examined return to work as a proxy of preserved function without major neurologic deficits in survivors. Methods and Results— In Denmark, out-of-hospital cardiac arrests have been systematically reported to the Danish Cardiac Arrest Register since 2001. During 2001–2011, we identified 4354 patients employed before arrest among 12 332 working-age patients (18–65 years), of whom 796 survived to day 30. Among 796 survivors (median age, 53 years [quartile 1–3, 46–59 years]; 81.5% men), 610 (76.6%) returned to work in a median time of 4 months [quartile 1–3, 1–19 months], with a median time of 3 years spent back at work. A total of 74.6% (N=455) remained employed without using sick leave during the first 6 months after returning to work. This latter proportion of survivors returning to work increased over time (66.1% in 2001–2005 versus 78.1% in 2006–2011; P =0.002). In multivariable Cox regression analysis, factors associated with return to work with ≥6 months of sustainable employment were as follows: (1) arrest during 2006–2011 versus 2001–2005, hazard ratio (HR), 1.38 (95% CI, 1.05–1.82); (2) male sex, HR, 1.48 (95% CI, 1.06–2.07); (3) age of 18 to 49 versus 50 to 65 years, HR, 1.32 (95% CI, 1.02–1.68); (4) bystander-witnessed arrest, HR, 1.79 (95% CI, 1.17–2.76); and (5) bystander cardiopulmonary resuscitation, HR, 1.38 (95% CI, 1.02–1.87). Conclusions— Of 30-day survivors employed before arrest, 76.6% returned to work. The percentage of survivors returning to work increased significantly, along with improved survival during 2001–2011, suggesting an increase in the proportion of survivors with preserved function over time. # CLINICAL PERSPECTIVE {#article-title-36}

The effect of Tai Chi on psychosocial well-being: a systematic review of randomized controlled trials

OBJECTIVE This systematic review aimed to critically appraise published clinical trials designed to assess the effect of Tai Chi on psychosocial well-being. DATA SOURCES Databases searched included MEDLINE, CINAHL, EMBASE, HEALT, PsycINFO, CISCOM, the Cochrane Central Register of Controlled Trials of the Cochrane Library, and dissertations and conference proceedings from inception to August 2008. REVIEW METHODS Methodological quality was assessed using a modified Jadad scale. A total of 15 studies met the inclusion criteria (i.e. English publications of randomized controlled trials with Tai Chi as an intervention and psychological well-being as an outcome measure), of which eight were high quality trials. The psychosocial outcomes measured included anxiety (eight studies), depression (eight studies), mood (four studies), stress (two studies), general mental health three studies), anger, positive and negative effect, self-esteem, life satisfaction, social interaction and self-rated health (one study each). RESULTS Tai Chi intervention was found to have a significant effect in 13 studies, especially in the management of depression and anxiety. Although the results seemed to suggest Tai Chi is effective, they should be interpreted cautiously as the quality of the trials varied substantially. Furthermore, significant findings were shown in only six high quality studies. Moreover, significant between group differences after Tai Chi intervention was demonstrated in only one high quality study (the other three significant results were observed in non-high quality studies). Two high quality studies in fact found no significant Tai Chi effects. CONCLUSION It is still premature to make any conclusive remarks on the effect of Tai Chi on psychosocial well-being.

Young Women With Type 1 Diabetes’ Management of Turning Points and Transitions

The authors used grounded theory to explore and develop a substantive theory to explain how 20 young women with type 1 diabetes managed their lives when facing turning points and undergoing transitions. The women experienced a basic social problem: being in the grip of blood glucose levels (BGLs), which consisted of three categories: (a) the impact of being susceptible to fluctuating BGLs, (b) the responses of other people to the individual woman’s diabetes, and (c) the impact of the individual women’s diabetes on other people’s lives. The women used a basic social process to overcome the basic social problem by creating stability, which involved using three interconnected subprocesses: forming meaningful relationships, enhancing attentiveness to blood glucose levels, and putting things in perspective. Insights into the processes and strategies used by the women have important implications for provision of care and service delivery.

Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest

BACKGROUND The effect of bystander interventions on long‐term functional outcomes among survivors of out‐of‐hospital cardiac arrest has not been extensively studied. METHODS We linked nationwide data on out‐of‐hospital cardiac arrests in Denmark to functional outcome data and reported the 1‐year risks of anoxic brain damage or nursing home admission and of death from any cause among patients who survived to day 30 after an out‐of‐hospital cardiac arrest. We analyzed risks according to whether bystander cardiopulmonary resuscitation (CPR) or defibrillation was performed and evaluated temporal changes in bystander interventions and outcomes. RESULTS Among the 2855 patients who were 30‐day survivors of an out‐of‐hospital cardiac arrest during the period from 2001 through 2012, a total of 10.5% had brain damage or were admitted to a nursing home and 9.7% died during the 1‐year follow‐up period. During the study period, among the 2084 patients who had cardiac arrests that were not witnessed by emergency medical services (EMS) personnel, the rate of bystander CPR increased from 66.7% to 80.6% (P<0.001), the rate of bystander defibrillation increased from 2.1% to 16.8% (P<0.001), the rate of brain damage or nursing home admission decreased from 10.0% to 7.6% (P<0.001), and all‐cause mortality decreased from 18.0% to 7.9% (P=0.002). In adjusted analyses, bystander CPR was associated with a risk of brain damage or nursing home admission that was significantly lower than that associated with no bystander resuscitation (hazard ratio, 0.62; 95% confidence interval [CI], 0.47 to 0.82), as well as a lower risk of death from any cause (hazard ratio, 0.70; 95% CI, 0.50 to 0.99) and a lower risk of the composite end point of brain damage, nursing home admission, or death (hazard ratio, 0.67; 95% CI, 0.53 to 0.84). The risks of these outcomes were even lower among patients who received bystander defibrillation as compared with no bystander resuscitation. CONCLUSIONS In our study, we found that bystander CPR and defibrillation were associated with risks of brain damage or nursing home admission and of death from any cause that were significantly lower than those associated with no bystander resuscitation. (Funded by TrygFonden and the Danish Heart Foundation.)

Mortality in elderly ICU patients: a cohort study.

The population is aging. We examined changes in the proportion of elderly (≥ 80 years) intensive care unit (ICU) patients during 2005–2011 and the association between age and mortality controlling for preexisting morbidity.

Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols: Results from the Danish On-pump Versus Off-pump Randomization Study (DOORS)

OBJECTIVE To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol. METHODS In a randomized, controlled, multicenter trial, 900 patients more than 70 years of age received either on-pump or off-pump coronary artery bypass surgery. Heparin was given to achieve an activated clotting time of 400 seconds before arteriotomy in both groups. After the procedure, protamine sulfate was given to revert the activated clotting time to less than 120 seconds. Coronary angiography was performed 6 months after the operation and graft patency was assessed by independent blinded observers. RESULTS A total of 481 patients underwent angiography. In the off-pump group, 561 (79%) of 710 grafts were open, 65 (9%) were stenotic, and 84 (12%) were occluded. In the on-pump group, 549 (86%) of 650 grafts were open, 38 (5%) were stenotic, and 63 (9%) were occluded. The difference between the proportion of open grafts was statistically significant in favor of on-pump surgery (P=.01). The proportion of open left internal thoracic artery grafts was 95% in both groups. Perioperative use of intracoronary shunts did not increase the risk of stenosis of the coronary artery distal to the anastomosis. CONCLUSIONS Despite comparable heparinization, graft patency after off-pump surgery was inferior to that after on-pump surgery.

Impact of size mismatch and left ventricular function on performance of the St. Jude disc valve after aortic valve replacement.

BACKGROUND The hemodynamic function of the St. Jude valve may change relative to changes in left ventricular function after aortic valve replacement for aortic stenosis. From theoretical reasons one may hypothesize that prosthetic valve hemodynamic function is related to left ventricular failure and mismatch between valve size and patient/ventricular chamber size. METHODS Forty patients aged 24 to 82 years who survived aortic valve replacement for aortic stenosis with a standard St. Jude disc valve (mean size, 23.5 mm; range, 19 to 29 mm) were followed up prospectively with Doppler echocardiography and radionuclide left ventriculography preoperatively and 9 days, 3 months, and 18 months after the operation with assessment of intravascular hemolysis at 18 months. Follow-up to a maximum of 7.4 years (mean, 6.3 years) was 100% complete. RESULTS Left ventricular muscle mass index decreased from 198 +/- 62 g.m-2 preoperatively to 153 +/- 53 g.m-2 at 18 months (p < 0.001), paralleled by a significant increase in left ventricular ejection fraction, peak ejection rate, and peak filling rate; only 18% of the patients had normal left ventricular muscle mass index and only 32% normal ventricular function (normal left ventricular ejection fraction, peak ejection rate, peak filling rate, early filling fraction, and late filling fraction during atrial contraction) at 18 months. Prosthetic valve peak Doppler gradient dropped from 20 +/- 6 mm Hg at 9 days to 17 +/- 5 mm Hg at 18 months (p < 0.05). Reduction of left ventricular muscle mass index was unrelated to peak gradient and size of the valve. Peak gradient at 18 months rose with valve orifice diameter of 17 mm or less (by 6 mm Hg), orifice diameter/body surface area of 9 mm.m-2 or less (by 5 mm Hg), left ventricular enddiastolic dimension (by 23 mm Hg per 10 mm increase), and impaired ventricular function (by 3 mm Hg). All but 2 patients (5%) had intravascular hemolysis; none had anemia. Two patients with moderate paravalvular leak had the highest serum lactic dehydrogenase levels; 4 patients with trivial leak had higher serum lactic dehydrogenase levels than those without leak. Serum lactic dehydrogenase levels rose with moderate paravalvular leak, impaired ventricular function, and valve orifice diameter. Six patients with trivial or moderate paravalvular leak had a cumulative 7-year freedom from bleeding and thromboembolism of 44% +/- 22% compared with 87% +/- 5% for those without leak (p < 0.05). CONCLUSIONS The peak gradient of the St. Jude aortic valve dropped marginally over the first 18 postoperative months in association with incomplete left ventricular hypertrophy regression and marginal improvement of ventricular function. Mismatch between valve size and ventricular cavity size or patient size and impaired function of a dilated ventricle significantly compromised the performance of the St. Jude valve. Probably explained by platelet destruction or activation, paravalvular leak was related to bleeding and thromboembolic complications.

Nursing Care of Clients Treated with Atypical Antipsychotics Who Have a Risk of Developing Metabolic Instability and/or Type 2 Diabetes

OBJECTIVE The aim of this article is to present a current discussion related to the nursing care of clients treated with atypical antipsychotic medicines and who have a risk of developing metabolic instability and/or Type 2 diabetes. The importance of such a discussion is to provide both the novice and the experienced nurse with additional knowledge of this current health issue with which to inform their nursing practice. DISCUSSION The potential for psychosis to be a chronic condition is very high, and often people require antipsychotic medicine for lengthy periods throughout their lives. Sometimes, treatment is for life. The second generation of antipsychotic medicines was greeted with much enthusiasm since it was better tolerated than the first generation. However, each medication has desired and adverse effects and, when taken for lengthy periods, these effects may produce physical illness. Studies show that the prevalence of Type 2 diabetes and the metabolic syndrome was significantly higher in clients with a chronic psychiatric disorder, particularly schizophrenia. CONCLUSIONS Metabolic instability, especially weight gain, is associated with some psychotropic medicines. Nursing interventions need to include care assessment, planning, intervention, and evaluation for clients treated with antipsychotic medicines in terms of risk minimization strategies in routine nursing care.