Browsing by Subject "INTENSIVE-CARE"

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  • Meyhoff, Tine Sylvest; Hjortrup, Peter Buhl; Moller, Morten Hylander; Wetterslev, Jorn; Lange, Theis; Kjaer, Maj-Brit Norregaard; Jonsson, Andreas Bender; Hjortso, Carl Johan Steensen; Cronhjort, Maria; Laake, Jon Henrik; Jakob, Stephan M.; Nalos, Marek; Pettilä, Ville; van der Horst, Iwan; Ostermann, Marlies; Mouncey, Paul; Rowan, Kathy; Cecconi, Maurizio; Ferrer, Ricard; Malbrain, Manu L. N. G.; Ahlstedt, Christian; Hoffmann, Soren; Bestle, Morten Heiberg; Nebrich, Lars; Russell, Lene; Vang, Marianne; Rasmussen, Michael Lindhardt; Solling, Christoffer; Rasmussen, Bodil Steen; Brochner, Anne Craveiro; Perner, Anders (2019)
    Introduction Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock. Methods CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.
  • Raj, R.; Bendel, S.; Reinikainen, M.; Hoppu, S.; Laitio, R.; Ala-Kokko, T.; Curtze, S.; Skrifvars, M. B. (2018)
    Background: Neurocritical illness is a growing healthcare problem with profound socioeconomic effects. We assessed differences in healthcare costs and long-term outcome for different forms of neurocritical illnesses treated in the intensive care unit (ICU). Methods: We used the prospective Finnish Intensive Care Consortium database to identify all adult patients treated for traumatic brain injury (TBI), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH) and acute ischemic stroke (AIS) at university hospital ICUs in Finland during 2003-2013. Outcome variables were one-year mortality and permanent disability. Total healthcare costs included the index university hospital costs, rehabilitation hospital costs and social security costs up to one year. All costs were converted to euros based on the 2013 currency rate. Results: In total 7044 patients were included (44% with TBI, 13% with ICH, 27% with SAH, 16% with AIS). In comparison to TBI, ICH was associated with the highest risk of death and permanent disability (OR 2.6, 95% CI 2.1-3.2 and OR 1.7, 95% CI 1.4-2.1), followed by AIS (OR 1.9, 95% CI 15-23 and OR 1.5, 95% CI 1.3-1.8) and SAH (OR 1.8, 95% CI 1.5-2.1 and OR 0. 8, 95% CI 0.6-0.9), after adjusting for severity of illness. SAH was associated with the highest mean total costs ((sic)51,906) followed by ICH ((sic)47,661), TBI ((sic)43,916) and AIS ((sic)39222). Cost per independent survivor was lower for TBI ((sic)58,497) and SAH ((sic)96,369) compared to AIS ((sic)104,374) and ICH ((sic)178,071). Conclusion: Neurocritical illnesses are costly and resource-demanding diseases associated with poor outcomes. Intensive care of patients with TBI or SAH more commonly result in independent survivors and is associated with lower total treatments costs compared to ICH and AIS.
  • Perner, Anders; Cecconi, Maurizio; Cronhjort, Maria; Darmon, Michael; Jakob, Stephan M.; Pettilä, Ville; van der Horst, Iwan C. C. (2018)
    Hypovolemia is frequent in patients with sepsis and may contribute to worse outcome. The management of these patients is impeded by the low quality of the evidence for many of the specific components of the care. In this paper, we discuss recent advances and controversies in this field and give expert statements for the management of hypovolemia in patients with sepsis including triggers and targets for fluid therapy and volumes and types of fluid to be given. Finally, we point to unanswered questions and suggest a roadmap for future research.
  • ARISE Investigators; Luethi, Nora; Bailey, Michael; Harjola, V-P; Okkonen, M.; Pettilä, V.; Sutinen, E.; Wilkman, E. (2020)
    Purpose: To assess the impact of gender and pre-menopausal state on short- and long-term outcomes in patients with septic shock. Material and methods: Cohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial, an international randomized controlled trial comparing early goal-directed therapy (EGDT) to usual care in patients with early septic shock, conducted between October 2008 and April 2014. The primary exposure in this analysis was legal gender and the secondary exposure was pre-menopausal state defined by chronological age ( Results: 641 (40.3%) of all 1591 ARISE trial participants in the intention-to-treat population were females and overall, 337 (21.2%) (146 females) patients were 50 years of age or younger. After risk-adjustment, we could not identify any survival benefit for female patients at day 90 in the younger (50 years) age-group (aOR: 1.10 (0.81-1.49), p = .56). Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures. Conclusions: This post-hoc analysis of a large multi-center trial in early septic shock has shown no short- or long-term survival effect for women overall as well as in the pre-menopausal age-group. (C) 2019 Elsevier Inc. All rights reserved.
  • Kjaer, Maj-Brit N.; Meyhoff, Tine S.; Madsen, Martin B.; Hjortrup, Peter B.; Moller, Morten Hylander; Egerod, Ingrid; Wetterslev, Jorn; Lange, Theis; Cronhjort, Maria; Laake, Jon H.; Jakob, Stephan M.; Nalos, Marek; Pettilä, Ville; van der Horst, Iwan C. C.; Ostermann, Marlies; Mouncey, Paul; Cecconi, Maurizio; Ferrer, Ricard; Malbrain, Manu L. N. G.; Ahlstedt, Christian; Hoffmann, Soren; Bestle, Morten H.; Gyldensted, Louise; Nebrich, Lars; Russell, Lene; Vang, Marianne; Solling, Christoffer; Brochner, Anne C.; Rasmussen, Bodil S.; Perner, Anders (2020)
    BackgroundIn patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes. AimTo assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial. MethodsIn this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function. DiscussionWith this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.
  • Suominen, Pertti K.; Vahatalo, Raisa (2012)
  • Lange, Theis; Skrifvars, Markus; Ranzani, Otavio T. (2018)
  • Hjortrup, Peter B.; Haase, Nicolai; Bundgaard, Helle; Thomsen, Simon L.; Winding, Robert; Pettilä, Ville; Aaen, Anne; Lodahl, David; Berthelsen, Rasmus E.; Christensen, Henrik; Madsen, Martin B.; Winkel, Per; Wetterslev, Jorn; Perner, Anders; CLASSIC Trial Grp; Scandinavian Critical Care Trials (2016)
    Purpose: We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock. Methods: We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve. Results: The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [ mean differences -1.2 L (95 % confidence interval -2.0 to -0.4); p <0.001 and -1.4 L (-2.4 to -0.4) respectively; p <0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08-1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23-0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36-1.40; p = 0.32). Conclusions: A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes.
  • Pelkonen, Tuula; Roine, Irmeli; Cruzeiro, Manuel Leite; Pitkäranta, Anne; Kataja, Matti; Peltola, Heikki (2011)
  • Tiainen, Marjaana; Vaahersalo, Jukka; Skrifvars, Markus B.; Hästbacka, Johanna; Grönlund, Juha; Pettilä, Ville (2018)
    Background: Data on long-term functional outcome and quality of life (QoL) after out-of-hospital cardiac arrest (OHCA) are limited. We assessed long-term functional outcome and health-related QoL of OHCA survivors regardless of arrest aetiology. Methods: All adult unconscious OHCA patients treated in 21 Finnish ICUs between March 2010 and February 2011 were followed. Barthel Index (BI), activities of daily living (ADL), accommodation, help needed and received, working status, car driving and self-experienced cognitive deficits were assessed in 1-year survivors (N = 206, 40.9% of the original FINNRESUSCI cohort) with a structured telephone interview. Health-related QoL and more complex ADL-functions were evaluated by EQ-5D and instrumental ADL questionnaires. Results: Good outcome, defined as Cerebral Performance Categories 1 or 2, had been reached by 90.3% of survivors. The median BI score was 100, and 91.3% of survivors were independent in basic ADL-functions. The great majority of survivors were living at home, only 8.7% lived in a sheltered home or needed institutionalized care. Of home-living survivors 71.4% scored high in instrumental ADL assessment. The majority (72.6%) of survivors who were working previously had returned to work. Health-related QoL was similar as in age-and gender-adjusted Finnish population. Conclusions: Long-term functional outcome was good in over 90% of patients surviving OHCA, with health-related quality of life similar to that of an age and gender matched population.
  • Raj, Rahul; Bendel, Stepani; Reinikainen, Matti; Hoppu, Sanna; Luoto, Teemu; Ala-Kokko, Tero; Tetri, Sami; Laitio, Ruut; Koivisto, Timo; Rinne, Jaakko; Kivisaari, Riku; Siironen, Jari; Higgins, Alisa; Skrifvars, Markus B. (2018)
    Objective: To assess temporal trends in 1-year healthcare costs and outcome of intensive care for traumatic brain injury in Finland. Design: Retrospective observational cohort study. Setting: Multicenter study including four tertiary ICUs. Patients: Three thousand fifty-one adult patients (>= 18 yr) with significant traumatic brain injury treated in a tertiary ICU during 2003-2013. Intervention: None. Measurements and Main Results: Total 1-year healthcare costs included the index hospitalization costs, rehabilitation unit costs, and social security reimbursements. All costs are reported as 2013 U.S. dollars ($). Outcomes were 1-year mortality and permanent disability. Multivariate regression models, adjusting for case-mix, were used to assess temporal trends in costs and outcome in predefined Glasgow Coma Scale (3-8, 9-12, and 13-15) and age (18-40, 41-64, and >= 65 yr) subgroups. Overall 1-year survival was 76% (n = 2,304), and of 1-year survivors, 37% (n = 850) were permanently disabled. Mean unadjusted 1-year healthcare cost was $39,809 (95% CI, $38,144-$41,473) per patient. Adjusted healthcare costs decreased only in the Glasgow Coma Scale 13-15 and 65 years and older subgroups, due to lower rehabilitation costs. Adjusted 1-year mortality did not change in any subgroup (p <0.05 for all subgroups). Adjusted risk of permanent disability decreased significantly in all subgroups (p <0.05). Conclusion: During the last decade, healthcare costs of ICU-admitted traumatic brain injury patients have remained largely the same in Finland. No change in mortality was noted, but the risk for permanent disability decreased significantly. Thus, our results suggest that cost-effectiveness of traumatic brain injury care has improved during the past decade in Finland.
  • Mildh, Henriikka; Pettilä, Ville; Korhonen, Anna-Maija; Karlsson, Sari; Ala-Kokko, Tero; Reinikainen, Matti; Vaara, Suvi; FINNAKI Study Grp (2016)
    Background: The role of an episode of acute kidney injury (AKI) in long-term mortality among initial survivors of critical illness is controversial. We aimed to determine whether AKI is independently associated with decreased survival at 3 years among 30-day survivors of intensive care. Results: We included 2336 30-day survivors of intensive care enrolled in the FINNAKI study conducted in seventeen medical-surgical ICUs in Finland during a 5-month period in 2011-2012. The incidence of AKI, defined by the Kidney Disease: Improving Global Outcomes criteria, was 34.6%, and 192 (8.3%) commenced RRT. The 3-year mortality among AKI patients was 23.5% (95% CI 20.6-26.4%) compared to 18.9% (17.0-20.9%) of patients without AKI, p = 0.01. However, after adjustments using Cox proportional hazards regression, AKI was not associated with decreased 3-year survival (HR 1.05; CI 95% 0.86-1.27), whereas advanced age, poor pre-morbid functional performance, and presence of several comorbidities were. Additionally, we matched AKI patients to non-AKI patients 1: 1 according to age, gender, presence of severe sepsis, and a propensity score to develop AKI. In the well-balanced matched cohort, 3-year mortality among AKI patients was 136 of 662 (20.5%; 17.5-23.6%) and among matched non-AKI patients 143 of 662 (21.6%; 18.5-24.7%), p = 0.687. Neither AKI nor RRT was associated with decreased survival at 3 years in the sensitivity analyses that excluded patients (1) with chronic kidney disease, (2) with AKI not commenced renal replacement therapy (RRT), and (3) with estimated pre-admission creatinine, chronic kidney disease, or AKI stage 1. Conclusion: AKI was not an independent risk factor for 3-year mortality among 30-day survivors. Increased 3-year mortality among patients with AKI who survive critical illness may not be related to AKI per se, but rather to advanced age and pre-existing comorbidities.