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Search Results: 1 - 10 of 2127 matches for " Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group "
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Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences
Deborah Cook, Ellen McDonald, Orla Smith, Nicole Zytaruk, Diane Heels-Ansdell, Irene Watpool, Tracy McArdle, Andrea Matte, France Clarke, Shirley Vallance, Simon Finfer, Pauline Galt, Tim Crozier, Rob Fowler, Yaseen Arabi, Clive Woolfe, Neil Orford, Richard Hall, Neill KJ Adhikari, Marie-Clauide Ferland, John Marshall, Maureen Meade, The PROTECT Research Coordinators, PROTECT Investigators, Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group
Critical Care , 2013, DOI: 10.1186/cc11917
Abstract: In an observational analysis of an international thromboprophylaxis trial in 67 ICUs, we examined the co-enrollment of critically ill medical-surgical patients into more than one study, and examined the clinical and trial outcomes among co-enrolled and non-co-enrolled patients.Among 3,746 patients enrolled in PROTECT (Prophylaxis for ThromboEmbolism in Critical Care Trial), 713 (19.0%) were co-enrolled in at least one other study (53.6% in a randomized trial, 37.0% in an observational study and 9.4% in both). Six factors independently associated with co-enrollment (all P < 0.001) were illness severity (odds ratio (OR) 1.35, 95% confidence interval (CI) 1.19 to 1.53 for each 10-point Acute Physiology and Chronic Health Evaluation (APACHE) II score increase), substitute decision-makers providing consent, rather than patients (OR 3.31, 2.03 to 5.41), experience of persons inviting consent (OR 2.67, 1.74 to 4.11 for persons with > 10 years' experience compared to persons with none), center size (all ORs > 10 for ICUs with > 15 beds), affiliation with trials groups (OR 5.59, 3.49 to 8.95), and main trial rather than pilot phase (all ORs > 8 for recruitment year beyond the pilot). Co-enrollment did not influence clinical or trial outcomes or risk of adverse events.Co-enrollment was strongly associated with features of the patients, research personnel, setting and study. Co-enrollment had no impact on trial results, and appeared safe, acceptable and feasible. Transparent reporting, scholarly discourse, ethical analysis and further research are needed on the complex topic of co-enrollment during critical illness.Clinical trials are essential to improve care and reduce morbidity and mortality in the intensive care unit (ICU). Some critically ill patients are eligible for more than one study. Restricting enrollment to only one study when patients are eligible for more than one is a potentially modifiable barrier to recruitment [1]. Testing two interventions concurrently can b
Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials
Daren K Heyland, John Muscedere, John Drover, Xuran Jiang, Andrew G Day, the Canadian Critical Care Trials Group
Critical Care , 2011, DOI: 10.1186/cc10110
Abstract: We performed a secondary analysis of a dataset from a prospective randomized trial involving 38 intensive care units (ICUs) in Canada, Europe, and the United States. We define POD as the persistence of organ dysfunction requiring supportive technologies during the convalescent phase of critical illness and it is present when a patient has an ongoing requirement for vasopressors, dialysis, or mechanical ventilation at the outcome assessments time points. In 600 patients enrolled in a randomized trial of nutrition therapy and followed prospectively for six months, we evaluated the prevalence of POD and its association with outcome.At 28 days, 2.3% of patients had circulatory failure, 13.7% had renal failure, 8.7% had respiratory failure, and 27.2% had died, for an overall prevalence of POD + death = 46.0%. Of survivors at Day 28, those with POD, compared to those without POD, had a higher mortality rate in the six-month follow-up period, had longer ICU and hospital stays, and a reduced quality of life at three months. Given these rates of POD + death and using a two-sided Chi-squared test at alpha = 0.05, we would require 616 patients per arm to detect a 25% relative risk reduction (RRR) in mortality, but only 286 per arm to detect the same RRR in POD + mortality.POD + death may be a valid composite outcome measure and compared to mortality endpoints, may reduce the sample size requirements of clinical trials of critically ill patients. Further validation in larger clinical trials is required.In the critical care setting, randomized controlled trials (RCTs) focusing on clinically important endpoints have become the preferred source of evidence on which to base clinical recommendations. However, due to resource limitations, few critical care interventions have been rigorously evaluated with adequately powered RCTs. There is a need to improve the efficiency of RCTs in critical care so that more definitive high quality RCTs can be completed with the available resources.T
A survey of Canadian intensivists' resuscitation practices in early septic shock
Lauralyn A McIntyre, Paul C Hébert, Dean Fergusson, Deborah J Cook, Ashique Aziz, the Canadian Critical Care Trials Group
Critical Care , 2007, DOI: 10.1186/cc5962
Abstract: A scenario-based self-administered national survey was sent out to Canadian critical care physicians. One hypothetical scenario was developed to obtain information on several aspects of resuscitation in early septic shock, including monitoring and resuscitation end-points, fluid administration, red blood cell transfusion triggers, and use of inotropes. The sampling frame was physician members of Canadian national and provincial critical care societies.The survey response rate was 232 out of 355 (65.3%). Medicine was the most common primary specialty (60.0%), most respondents had practiced for 6 to 10 years (30.0%), and 82.0% were male. The following monitoring devices/parameters were reported as used/measured 'often' or 'always' by at least 89% of respondents: oxygen saturation (100%), Foley catheters (100%), arterial blood pressure lines (96.6%), telemetry (94.3%), and central venous pressure (89.2%). Continuous monitoring of central venous oxygen saturation was employed 'often' or 'always' by 9.8% of respondents. The two most commonly cited resuscitation end-points were urine output (96.5%) and blood pressure (91.8%). Over half of respondents used normal saline (84.5%), Ringers lactate (52.2%), and pentastarch (51.3%) 'often' or 'always' for early fluid resuscitation. In contrast, 5% and 25% albumin solutions were cited as used 'often' or 'always' by 3.9% and 1.3% of respondents, respectively. Compared with internists, surgeons and anesthesiologists (odds ratio (95% confidence interval): 9.8 (2.9 to 32.7) and 3.8 (1.7 to 8.7), respectively) reported greater use of Ringers lactate. In the setting of a low central venous oxygen saturation, 52.5% of respondents reported use of inotropic support 'often' or 'always'. Only 7.6% of physicians stated they would use a red blood cell transfusion trigger of 100 g/l to optimize oxygen delivery further.Our survey results suggest that there is substantial practice variation in the resuscitation of adult patients with early sept
Clinically important deep vein thrombosis in the intensive care unit: a survey of intensivists
Deborah Cook, Maureen Meade, Gordon Guyatt, Lauren Griffith, John Granton, William Geerts, Mark Crowther, the Canadian Critical Care Trials Group
Critical Care , 2004, DOI: 10.1186/cc2859
Abstract: Our definition of clinically important DVT was a DVT likely to result in short-term or long-term morbidity or mortality if left untreated, as opposed to a DVT that is unlikely to have important consequences. We asked respondents to indicate the likelihood that patient factors and ultrasonographic features make a DVT clinically important using a five-point scale (from 1 = much less likely to 5 = much more likely).Of the 71 Canadian intensivists who responded, 70 (99%) rated three patient factors as most likely to make a DVT clinically important: clinical suspicion of pulmonary embolism (mean score 4.6), acute or chronic cardiopulmonary morbidity that might limit a patient's ability to tolerate pulmonary embolism (score 4.5), and leg symptoms (score 4.2). Of the ultrasound features, proximal (score 4.7), large (score 4.2), and totally occlusive (score 3.9) thrombi were considered the three most important.When labeling a DVT as clinically important, intensivists rely on different patient specific factors and thrombus characteristics than are used to assess the clinical importance of DVT outside the ICU. The clinical importance of DVT is influenced by unique factors such as cardiopulmonary reserve among mechanically ventilated patients.Venous thromboembolism (VTE), which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication of critical illness [1,2]. Critically ill patients harbor many coincident risk factors for DVT, such as the need for surgery, catheters, immobility, and use of sedatives and paralytic agents [3-5]. As in the noncritically ill population, it is likely that most episodes of DVT are asymptomatic and confined to the deep veins of the calf. However, with time, 20–30% of untreated calf vein thrombi extend proximally into the thigh, where they pose a 40–50% risk for PE [6]. Early studies of the natural history of PE suggest that untreated PE has a mortality rate of at least 25% [7].One large study found PE at autopsy
Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials
Manoj M. Lalu, Lauralyn McIntyre, Christina Pugliese, Dean Fergusson, Brent W. Winston, John C. Marshall, John Granton, Duncan J. Stewart, Canadian Critical Care Trials Group
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0047559
Abstract: Background Mesenchymal stromal cells (MSCs, “adult stem cells”) have been widely used experimentally in a variety of clinical contexts. There is interest in using these cells in critical illness, however, the safety profile of these cells is not well known. We thus conducted a systematic review of clinical trials that examined the use MSCs to evaluate their safety. Methods and Findings MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (to June 2011), were searched. Prospective clinical trials that used intravascular delivery of MSCs (intravenously or intra-arterially) in adult populations or mixed adult and pediatric populations were identified. Studies using differentiated MSCs or additional cell types were excluded. The primary outcome adverse events were grouped according to immediate events (acute infusional toxicity, fever), organ system complications, infection, and longer term adverse events (death, malignancy). 2347 citations were reviewed and 36 studies met inclusion criteria. A total of 1012 participants with clinical conditions of ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy volunteers were included. Eight studies were randomized control trials (RCTs) and enrolled 321 participants. Meta-analysis of the RCTs did not detect an association between acute infusional toxicity, organ system complications, infection, death or malignancy. There was a significant association between MSCs and transient fever. Conclusions Based on the current clinical trials, MSC therapy appears safe. However, further larger scale controlled clinical trials with rigorous reporting of adverse events are required to further define the safety profile of MSCs.
The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients
Deborah J Cook, Lauren E Griffith, Stephen D Walter, Gordon H Guyatt, Maureen O Meade, Daren K Heyland, Ann Kirby, Michael Tryba, for the Canadian Critical Care Trials Group
Critical Care , 2001, DOI: 10.1186/cc1071
Abstract: Three strategies were used to estimate the mortality attributable to bleeding in two multicentre databases. The first method matched patients who bled with those who did not (matched cohort), using duration of ICU stay prior to the bleed, each of six domains of the Multiple Organ Dysfunction Score (MODS) measured 3 days prior to the bleed, APACHE II score, age, admitting diagnosis, and duration of mechanical ventilation. The second approach employed Cox proportional hazards regression to match bleeding and non-bleeding patients (model-based matched cohort). The third method, instead of matching, derived estimates based on regression modelling using the entire population (regression method). Three parallel analyses were conducted for the length of ICU stay attributable to clinically important bleeding.Sixteen Canadian university-affiliated ICUs.A total of 1666 critically ill patients receiving mechanical ventilation for at least 48 hours.We prospectively collected data on patient demographics, APACHE II score, admitting diagnosis, daily MODS, clinically important bleeding, length of ICU stay, and mortality. Independent adjudicators determined the occurrence of clinically important gastrointestinal bleeding, defined as overt bleeding in association with haemodynamic compromise or blood transfusion.Of 1666 patients, 59 developed clinically important gastrointestinal bleeding. The mean APACHE II score was 22.9 ± 8.6 among bleeding patients and 23.3 ± 7.7 among non-bleeding patients. The risk of death was increased in patients with bleeding using all three analytic approaches (matched cohort method: relative risk [RR]= 2.9, 95% confidence interval (CI)= 1.6–5.5; model-based matched cohort method: RR = 1.8, 95% CI = 1.1–2.9; and the regression method: RR = 4.1, 95% CI = 2.6–6.5). However, this was not significant for the adjusted regression method (RR = 1.0, 95% CI = 0.6–1.7). The median length of ICU stay attributable to clinically important bleeding for these three meth
Intensive care for the adult population in Ireland: a multicentre study of intensive care population demographics
The Irish Critical Care Trials Group
Critical Care , 2008, DOI: 10.1186/cc7018
Abstract: A prospective observational multicentre study of demographics and organ failure incidence was carried out over a 10-week period in 2006 across the intensive care units (ICUs) of 14 hospitals in both the Republic and Northern Ireland.In total, there were 1,029 patient episodes entered across 14 ICUs. Emergency admissions accounted for 70% of episodes. Admissions after major elective surgery accounted for 20.5% of admissions. The mean length of ICU stay was 5.7 days, with a median of 2 days. Severe sepsis was identified in 35% of patients during their ICU admission. Mechanical ventilation was used in 70.7% of all patients admitted, of whom 26.9% had acute lung injury. Acute kidney injury occurred in 28% of all patients. Interhospital transfers were undertaken in 85 (8.3%) patients. The overall intensive care mortality of the study population was 19%.Intensive care medicine in Ireland serves a patient population with high requirement for mechanical ventilation and support of the function of multiple organs. The overall mortality compares favourably with international benchmarks.The Irish Critical Care Trials Group (ICCTG) was formed in 2006 with the aim of improving the capacity to conduct high-quality clinical research in the critically ill in Ireland. For many years in Ireland, clinicians in critical care medicine have participated in international multicentre trials and collaborated with such trials groups such as the European Society of Intensive Care Medicine and more recently its European Critical Care Research Network Group, and the Australia and New Zealand Intensive Care Clinical Society Trials Group, or have conducted focused studies within their own critical care population.In order to inform hypotheses, feasibility and design of multicentre clinical trials, there was a need to first define the epidemiology of the potential study population. The ability of the participating units to complete the study was an important outcome measure for further collaborativ
Acute lung injury and the acute respiratory distress syndrome in Ireland: a prospective audit of epidemiology and management
The Irish Critical Care Trials Group
Critical Care , 2008, DOI: 10.1186/cc6808
Abstract: As part of a 10-week prospective national audit of patient demographics and organ failure incidence in intensive care in Ireland, all patients with ALI/ARDS in 14 participating centres were prospectively identified using American European Consensus Conference definitions.There were 1,029 admissions during the study period; of these, 728 patients were invasively ventilated. A total of 196 (19%) patients had ALI/ARDS, and 141 of these (72%) had ALI/ARDS on admission and a further 55 (28%) developed ALI/ARDS after admission. For the patients with ALI/ARDS, the mean (± standard deviation) age was 58 ± 17 years and 62% were male. The most common predisposing risk factors were pneumonia (50%) and nonpulmonary sepsis (26%). Mean (± standard deviation) tidal volume/kg was 7.0 ± 1.7 ml/kg. Median (interquartile range) duration of ventilation was 6.8 (2.0 to 12.8) days. Median (interquartile range) length of stay in the intensive care unit was 10.0 (5.0 to 18.5) days. The overall intensive care unit mortality for ALI/ARDS was 32.3%. Lower baseline arterial oxygen tension/fraction of inspired oxygen ratio and higher Sequential Organ Failure Assessment scores were associated with increased mortality. Although not significant, patients receiving treatment with a statin during admission had a 73% lower odds of death (odds ratio 0.27, 95% confidence interval 0.06 to 1.21; P = 0.09).The incidence of ALI/ARDS is high and is associated with significant mortality. Protective lung ventilation is used commonly throughout participating centres. With low tidal volume ventilation, the degree of hypoxaemia is associated with outcome. These data will inform future multicentre clinical trials in ALI/ARDS in Ireland.Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) occur in response to a variety of insults and are characterized by the development of noncardiogenic pulmonary oedema, impaired gas exchange and need for mechanical ventilation. ALI/ARDS is a major cause of
Recombinant human erythropoietin therapy in critically ill patients: a dose-response study [ISRCTN48523317]
Dimitris Georgopoulos, Dimitris Matamis, Christina Routsi, Argiris Michalopoulos, Nina Maggina, George Dimopoulos, Epaminondas Zakynthinos, George Nakos, George Thomopoulos, Kostas Mandragos, Alice Maniatis, the Critical Care Clinical Trials Greek Group
Critical Care , 2005, DOI: 10.1186/cc3786
Abstract: This was a prospective, randomized, multicentre trial. A total of 13 intensive care units participated, and a total of 148 patients who met eligibility criteria were enrolled. Patients were randomly assigned to receive intravenous iron saccharate alone (control group), intravenous iron saccharate and subcutaneous rHuEPO 40,000 units once per week (group A), or intravenous iron saccharate and subcutaneous rHuEPO 40,000 units three times per week (group B). rHuEPO was given for a minimum of 2 weeks or until discharge from the intensive care unit or death. The maximum duration of therapy was 3 weeks.The cumulative number of RBC units transfused, the average numbers of RBC units transfused per patient and per transfused patient, the average volume of RBCs transfused per day, and the percentage of transfused patients were significantly higher in the control group than in groups A and B. No significant difference was observed between group A and B. The mean increases in Hct and Hb from baseline to final measurement were significantly greater in group B than in the control group. The mean increase in Hct was significantly greater in group B than in group A. The mean increase in Hct in group A was significantly greater than that in control individuals, whereas the mean increase in Hb did not differ significantly between the control group and group A.Administration of rHuEPO to critically ill patients significantly reduced the need for RBC transfusion. The magnitude of the reduction did not differ between the two dosing schedules, although there was a dose response for Hct and Hb to rHuEPO in these patients.Anaemia is a common problem in critically ill patients [1,2]. Indeed, it has been shown that, at intensive care unit (ICU) admission, mean haemoglobin (Hb) concentration in critically ill patients is about 11 g/dl, and in 60% and 30% of them the mean Hb is less than 12 and 10 g/dl, respectively. Thus, the majority of critically ill patients exhibit anaemia upon ICU admiss
Variation in red cell transfusion practice in the intensive care unit: a multicentre cohort study
Paul C Hébert, George Wells, Claudio Martin, Martin Tweeddale, John Marshall, Morris Blajchman, Giuseppe Pagliarello, Dean Sandham, Irwin Schweitzer, Denis Boisvert, Lisa Calder, for the Transfusion Requirements in Critical Care (TRICC) Investigators and the Canadian Critical Care Trials Group
Critical Care , 1999, DOI: 10.1186/cc310
Abstract: Multicentre cohort study combined with a cross-sectional survey of physicians requesting red cell transfusions for patients in the cohort.The cohort included 5298 consecutive patients admitted to six tertiary level intensive care units in addition to administering a survey to 223 physicians requesting red cell transfusions in these units.Haemoglobin concentrations were collected, along with the number and reasons for red cell transfusions plus demographic, diagnostic, disease severity (APACHE II score), intensive care unit (ICU) mortality and lengths of stay in the ICU.Twenty five per cent of the critically ill patients in the cohort study received red cell transfusions. The overall number of transfusions per patient-day in the ICU averaged 0.95 ± 1.39 and ranged from 0.82 ± 1.69 to 1.08 ± 1.27 between institutions (P < 0.001). Independent predictors of transfusion thresholds (pre-transfusion haemoglobin concentrations) included patient age, admission APACHE II score and the institution (P < 0.0001). A very significant institution effect (P < 0.0001) persisted even after multivariate adjustments for age, APACHE II score and within four diagnostic categories (cardiovascular disease, respiratory failure, major surgery and trauma) (P < 0.0001). The evaluation of transfusion practice using the bedside survey documented that 35% (202 of 576) of pre-transfusion haemoglobin concentrations were in the range of 95-105 g/l and 80% of the orders were for two packed cell units. The most frequent reasons for administering red cells were acute bleeding (35%) and the augmentation of O2 delivery (25%).There is significant institutional variation in critical care transfusion practice, many intensivists adhering to a 100g/l threshold, and opting to administer multiple units despite published guidelines to the contrary. There is a need for prospective studies to define optimal practice in the critically ill.Physicians commonly used a threshold of 100g/l (haematocrit of 30%) as the lev
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