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Sökning: WFRF:(Cronberg T)

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1.
  • Dankiewicz, J., et al. (författare)
  • Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest
  • 2021
  • Ingår i: New England Journal of Medicine. - : MASSACHUSETTS MEDICAL SOC. - 0028-4793 .- 1533-4406. ; 384:24, s. 2283-2294
  • Tidskriftsartikel (refereegranskat)abstract
    • Hypothermia or Normothermia after Cardiac Arrest This trial randomly assigned patients with coma after out-of-hospital cardiac arrest to undergo targeted hypothermia at 33 degrees C or normothermia with treatment of fever. At 6 months, there were no significant between-group differences regarding death or functional outcomes. Background Targeted temperature management is recommended for patients after cardiac arrest, but the supporting evidence is of low certainty. Methods In an open-label trial with blinded assessment of outcomes, we randomly assigned 1900 adults with coma who had had an out-of-hospital cardiac arrest of presumed cardiac or unknown cause to undergo targeted hypothermia at 33 degrees C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, >= 37.8 degrees C). The primary outcome was death from any cause at 6 months. Secondary outcomes included functional outcome at 6 months as assessed with the modified Rankin scale. Prespecified subgroups were defined according to sex, age, initial cardiac rhythm, time to return of spontaneous circulation, and presence or absence of shock on admission. Prespecified adverse events were pneumonia, sepsis, bleeding, arrhythmia resulting in hemodynamic compromise, and skin complications related to the temperature management device. Results A total of 1850 patients were evaluated for the primary outcome. At 6 months, 465 of 925 patients (50%) in the hypothermia group had died, as compared with 446 of 925 (48%) in the normothermia group (relative risk with hypothermia, 1.04; 95% confidence interval [CI], 0.94 to 1.14; P=0.37). Of the 1747 patients in whom the functional outcome was assessed, 488 of 881 (55%) in the hypothermia group had moderately severe disability or worse (modified Rankin scale score >= 4), as compared with 479 of 866 (55%) in the normothermia group (relative risk with hypothermia, 1.00; 95% CI, 0.92 to 1.09). Outcomes were consistent in the prespecified subgroups. Arrhythmia resulting in hemodynamic compromise was more common in the hypothermia group than in the normothermia group (24% vs. 17%, P<0.001). The incidence of other adverse events did not differ significantly between the two groups. Conclusions In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not lead to a lower incidence of death by 6 months than targeted normothermia. (Funded by the Swedish Research Council and others; TTM2 ClinicalTrials.gov number, .)
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2.
  • Dankiewicz, J., et al. (författare)
  • Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial - Rationale and design
  • 2019
  • Ingår i: American Heart Journal. - : Mosby. - 0002-8703 .- 1097-6744. ; 217, s. 23-31
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Less than 500 participants have been included in randomized trials comparing hypothermia with regular care for out-of-hospital cardiac arrest patients, and many of these trials were small and at a high risk of bias. Consequently, the accrued data on this potentially beneficial intervention resembles that of a drug following small phase II trials. A large confirmatory trial is therefore warranted. Methods: The TTM2-trial is an international, multicenter, parallel group, investigator-initiated, randomized, superiority trial in which a target temperature of 33°C after cardiac arrest will be compared with a strategy to maintain normothermia and early treatment of fever (≥37.8°C). Participants will be randomized within 3 hours of return of spontaneous circulation with the intervention period lasting 40 hours in both groups. Sedation will be mandatory for all patients throughout the intervention period. The clinical team involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention. Prognosticators, outcome-assessors, the steering group, the trial coordinating team, and trial statistician will be blinded. The primary outcome will be all-cause mortality at 180 days after randomization. We estimate a 55% mortality in the control group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4–6) at 180 days after arrest. Discussion: The TTM2-trial will compare hypothermia to 33°C with normothermia and early treatment of fever (≥37.8°C) after out-of-hospital cardiac arrest. © 2019
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3.
  • Djärv, Therese, et al. (författare)
  • Health-related quality of life after surviving an out-of-hospital compared to an in-hospital cardiac arrest : a Swedish population-based registry study
  • 2020
  • Ingår i: Resuscitation. - : Elsevier. - 0300-9572 .- 1873-1570. ; 151, s. 77-84
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundHealth-related quality of life (HRQoL) has been reported for out-hospital (OHCA) and in-hospital cardiac arrest (IHCA) separately, but potential differences between the two groups are unknown. The aim of this study is therefore to describe and compare HRQoL in patients surviving OHCA and IHCA.MethodsPatients ≥18 years with Cerebral Performance Category 1–3 included in the Swedish Registry for Cardiopulmonary Resuscitation between 2014 and 2017 were included. A telephone interview was performed based on a questionnaire sent 3–6 months post cardiac arrest, including EQ-5D-5L and the Hospital Anxiety and Depression Scale. Mann–Whitney U test and multiple linear- and ordinal logistic regression analyses were used to describe and compare HRQoL in OHCA and IHCA survivors. Adjustments were made for sex, age and initial rhythm.ResultsIn all, 1369 IHCA and 772 OHCA survivors were included. Most OHCA and IHCA survivors reported no symptoms of with anxiety (88% and 84%) or depression (87% and 85%). IHCA survivors reported significantly more problems in the health domains mobility, self-care, usual activities and pain/discomfort (p < 0.001 for all) and scored lower general health measured by EQ-VAS (median 70 vs. 80 respectively, p < 0.001) compared with the OHCA survivors.ConclusionSurvivors of IHCA reported significantly worse HRQoL compared to survivors of OHCA. Consequently, research data gathered from one of these populations may not be generalizable to the other.
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4.
  • Gisela, Lilja, et al. (författare)
  • Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest
  • 2018
  • Ingår i: Circulation-Cardiovascular Quality and Outcomes. - : Lippincott Williams & Wilkins. - 1941-7705 .- 1941-7713. ; 11:1
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The aim of this study was to describe out-of-hospital cardiac arrest (OHCA) survivors' ability to participate in activities of everyday life and society, including return to work. The specific aim was to evaluate potential effects of cognitive impairment. METHODS AND RESULTS: Two hundred eighty-seven OHCA survivors included in the TTM trial (Target Temperature Management) and 119 matched control patients with ST-segment-elevation myocardial infarction participated in a follow-up 180 days post-event that included assessments of participation, return to work, emotional problems, and cognitive impairment. On the Mayo-Portland Adaptability Inventory-4 Participation Index, OHCA survivors (n=270) reported more restricted participation In everyday life and in society (47% versus 30%; P<0.001) compared with ST-segment-elevation myocardial infarction controls (n=118). Furthermore, 27% (n=36) of pre-event working OHCA survivors (n=135) compared with 7% (n=3) of pre-event working ST-segment-elevation myocardial infarction controls (n=45) were on sick leave (odds ratio, 4.9; 95% confidence interval, 1.4-16.8; P=0.01). Among the OHCA survivors assumed to return to work (n=135), those with cognitive impairment (n=55) were 3x more likely (odds ratio, 3.3; 95% confidence interval, 1.2-9.3; P=0.02) to be on sick leave compared with those without cognitive impairment (n=40; 36%, n=20, versus 15%, n=6). For OHCA survivors, the variables that were found most predictive for a lower participation were depression, restricted mobility, memory impairment, novel problem-solving difficulties, fatigue, and slower processing speed. CONCLUSIONS: OHCA survivors reported a more restricted societal participation 6 months post-arrest, and their return to work was lower compared with ST-segment-elevation myocardial infarction controls. Cognitive impairment was significantly associated with lower participation, together with the closely related symptoms of fatigue, depression, and restricted mobility. These predictive variables may be used during follow-up to identify OHCA survivors at risk of a less successful recovery that may benefit from further support and rehabilitation.
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5.
  • Heimburg, K., et al. (författare)
  • Physical activity after cardiac arrest; protocol of a sub-study in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2)
  • 2021
  • Ingår i: Resuscitation Plus. - : Elsevier. - 2666-5204. ; 5
  • Tidskriftsartikel (refereegranskat)abstract
    • Aims: The primary aim of this study is to investigate whether out-of-hospital cardiac arrest (OHCA) survivors have lower levels of self-reported physical activity compared to a non-cardiac arrest (CA) control group who had acute myocardial infarction (MI). Additional aims are to explore potential predictors of physical inactivity (older age, female gender, problems with general physical function, global cognition, mental processing speed/attention, anxiety symptoms, depression symptoms, kinesiophobia, fatigue), and to investigate the relationship between self-reported and objectively measured physical activity among OHCA-survivors. Methods: The Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2-trial) collects information regarding age, gender, self-reported physical activity, general physical function, global cognition and mental processing speed/attention at 6 months after OHCA. In this TTM2-trial cross-sectional prospective sub-study, participants at selected sites are invited to an additional follow-up meeting within 4 weeks from the main study follow-up. At this meeting, information regarding anxiety symptoms, depression symptoms, kinesiophobia and fatigue is collected. The OHCA-survivors are then provided with an objective measure of physical activity, a hip-placed accelerometer, to wear for one week, together with a training diary. At the end of the week, participants are asked to once again answer two self-reported questions regarding physical activity for that specific week. MI-controls attend a single follow-up meeting and perform the same assessments as the OHCA-survivors, except from wearing the accelerometer. We aim to include 110 OHCA-survivors and 110 MI-controls in Sweden, Denmark and the United Kingdom. Conclusion: The results from this sub-study will provide novel information about physical activity among OHCA-survivors.
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6.
  • Israelsson, Johan, et al. (författare)
  • Health status and psychological distress among in-hospital cardiac arrest survivors in relation to gender.
  • 2017
  • Ingår i: Resuscitation. - : ELSEVIER IRELAND LTD. - 1873-1570 .- 0300-9572. ; 114, s. 27-33
  • Tidskriftsartikel (refereegranskat)abstract
    • To describe health status and psychological distress among in-hospital cardiac arrest (IHCA) survivors in relation to gender.This national register study consists of data from follow-up registration of IHCA survivors 3-6 months post cardiac arrest (CA) in Sweden. A questionnaire was sent to the survivors, including measurements of health status (EQ-5D-5L) and psychological distress (HADS).Between 2013 and 2015, 594 IHCA survivors were included in the study. The median values for EQ-5D-5L index and EQ VAS among survivors were 0.78 (q1-q3=0.67-0.86) and 70 (q1-q3=50-80) respectively. The values were significantly lower (p<0.001) in women compared to men. In addition, women reported more problems than men in all dimensions of EQ-5D-5L, except self-care. A majority of the respondents reported no problems with anxiety (85.4%) and/or symptoms of depression (87.0%). Women reported significantly more problems with anxiety (p<0.001) and symptoms of depression (p<0.001) compared to men. Gender was significantly associated with poorer health status and more psychological distress. No interaction effects for gender and age were found.Although the majority of survivors reported acceptable health status and no psychological distress, a substantial proportion reported severe problems. Women reported worse health status and more psychological distress compared to men. Therefore, a higher proportion of women may be in need of support. Health care professionals should make efforts to identify health problems among survivors and offer individualised support when needed.
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7.
  • Jakobsen, Janus Christian, et al. (författare)
  • Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.
  • 2020
  • Ingår i: Trials. - : BioMed Central (BMC). - 1745-6215. ; 21:1
  • Tidskriftsartikel (refereegranskat)abstract
    • To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan.This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.
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9.
  • Andersson, P., et al. (författare)
  • Predicting neurological outcome after out-of-hospital cardiac arrest with cumulative information; development and internal validation of an artificial neural network algorithm
  • 2021
  • Ingår i: Critical Care. - : BioMed Central (BMC). - 1364-8535. ; 25:1
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundPrognostication of neurological outcome in patients who remain comatose after cardiac arrest resuscitation is complex. Clinical variables, as well as biomarkers of brain injury, cardiac injury, and systemic inflammation, all yield some prognostic value. We hypothesised that cumulative information obtained during the first three days of intensive care could produce a reliable model for predicting neurological outcome following out-of-hospital cardiac arrest (OHCA) using artificial neural network (ANN) with and without biomarkers.MethodsWe performed a post hoc analysis of 932 patients from the Target Temperature Management trial. We focused on comatose patients at 24, 48, and 72 h post-cardiac arrest and excluded patients who were awake or deceased at these time points. 80% of the patients were allocated for model development (training set) and 20% for internal validation (test set). To investigate the prognostic potential of different levels of biomarkers (clinically available and research-grade), patients' background information, and intensive care observation and treatment, we created three models for each time point: (1) clinical variables, (2) adding clinically accessible biomarkers, e.g., neuron-specific enolase (NSE) and (3) adding research-grade biomarkers, e.g., neurofilament light (NFL). Patient outcome was the dichotomised Cerebral Performance Category (CPC) at six months; a good outcome was defined as CPC 1-2 whilst a poor outcome was defined as CPC 3-5. The area under the receiver operating characteristic curve (AUROC) was calculated for all test sets.ResultsAUROC remained below 90% when using only clinical variables throughout the first three days in the ICU. Adding clinically accessible biomarkers such as NSE, AUROC increased from 82 to 94% (p<0.01). The prognostic accuracy remained excellent from day 1 to day 3 with an AUROC at approximately 95% when adding research-grade biomarkers. The models which included NSE after 72 h and NFL on any of the three days had a low risk of false-positive predictions while retaining a low number of false-negative predictions.ConclusionsIn this exploratory study, ANNs provided good to excellent prognostic accuracy in predicting neurological outcome in comatose patients post OHCA. The models which included NSE after 72 h and NFL on all days showed promising prognostic performance.
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10.
  • Bohm, Mattias, et al. (författare)
  • Detailed analysis of health-related quality of life after out-of-hospital cardiac arrest
  • 2019
  • Ingår i: Resuscitation. - : Elsevier. - 0300-9572 .- 1873-1570. ; 135, s. 197-204
  • Tidskriftsartikel (refereegranskat)abstract
    • Aim: To describe the detailed health-related quality of life (HRQoL) in survivors from the TTM-trial and to investigate potential differences related to sex and age. Methods: This is a cross-sectional study originating from a large prospective international, multicentre trial, including 442 respondents who answered the Short Form-36 item Questionnaire Health Survey version 2® (SF-36v2®) at a structured follow-up 6 months after out-of-hospital cardiac arrest (OHCA). Statistical analysis between independent groups were performed with Mann-Whitney U or Chi-square. Age was analysed primarily as a dichotomised variable. Results: Although overall physical and mental health were within the normal range, a substantial proportion of respondents had impaired function at domain-specific levels, particularly in Role-Physical (50%) and Role-Emotional (35%). Females scored significantly lower than males in; Physical Functioning (41.7 vs. 47.9, p < 0.001), Role-Physical (40.4 vs. 44.3, p = 0.02), General Health (47.0 vs. 50.5, p = 0.02), Vitality (47.2 vs. 52.7, p < 0.001), and Role-Emotional (41.5 vs. 46.2, p = 0.009). Those ≤65 years scored significantly better in Physical Functioning (47.9 vs. 44.1 p < 0.001), while those >65 years scored significantly better in Vitality (50.8 vs. 53.7, p = 0.006) and Mental Health (50.3 vs. 52.6, p = 0.04). Conclusions: Many OHCA survivors demonstrated impaired function in HRQoL at a domain level, despite most patients reporting an acceptable general HRQoL. Females reported worse HRQoL than males. Older age was associated with a worse Physical Functioning but better Vitality and Mental Health. Role-Physical and Role-Emotional aspects of health were especially affected, even when effects of age and sex where accounted for.
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