Introduction:
Rates of successful organ donation vary between otherwise comparable intensive care units (ICUs). The ICU staff have a unique perspective into the facilitators and barriers underlying ...this variation in successful deceased organ donation.
Research Question:
What do ICU staff perceive to be the most meaningful facilitators and barriers to deceased organ donation?
Design:
We designed and conducted a survey of all disciplines working in the ICU to ascertain the perceived facilitators and barriers to donation in an academic tertiary care hospital. Survey reliability was assessed using Cronbach α. Factor analysis was used to assess construct validity and identify potentially redundant survey items.
Results:
We had responses from 108 ICU staff, including nurses (n = 75), respiratory therapists (n = 14), physicians (n = 12), chaplains (n = 2), as well as social work, pharmacy, physiotherapy, and occupational therapy (n = 1 each). Perceived facilitators included availability of organ donation organization coordinators, explicit institutional support for donation, ICU staff culture toward donation, standardized order sets for donation, presence of ICU staff with donation experience, and bedside nurse presence at discussions about donation. Perceived barriers included ICU staff ruling out potentially suitable donors before consulting a donor coordinator, physician communication skills, low priority for organ donation among operating room staff, limited family understanding of patient prognosis and organ donation, and limited emotional readiness of families to discuss donation.
Discussion:
Several staff-perceived facilitators and barriers to deceased organ donation were identified in the ICU. Future research could identify strategies to promote these facilitators and overcome barriers.
There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether ...LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial.
We studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance CrCl <30 ml/min; post hoc subgroup; n = 590). We compared dalteparin, 5000 IU daily, with unfractionated heparin (UFH), 5000 IU twice daily, and considered outcomes of proximal leg deep vein thrombosis (DVT); pulmonary embolism (PE); any VTE; and major bleeding. Adjusted hazard ratios HR were calculated using Cox regression.
In patients with ESRD, there was no significant difference in DVT (8.3% vs. 5.2%, p = 0.76), any VTE (10.0% vs. 6.9%; p = 0.39) or major bleeding (5.0% vs. 8.6%; p = 0.32) between UFH and dalteparin. In patients with severe renal dysfunction, there was no significant difference in any VTE (10.0% vs. 6.4%; p = 0.07) or major bleeding (8.9% vs. 11.0%; p = 0.66) but an increase in DVT with dalteparin (7.6% vs. 3.7%; p = 0.04). Interaction p-values for comparisons of HRs (ESRD versus not) were non-significant.
In critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought ...to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.
The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial.
The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.
ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.
The purpose of this study is to describe the prevalence, to analyze the incidence and independent risk factors for thrombocytopenia, and to examine the impact of thrombocytopenia developing in the ...intensive care unit (ICU) on patient outcome in a well-defined cohort of critically ill patients in a medical-surgical ICU.
As part of a prospective cohort study examining the frequency and clinical importance of venous thromboembolism in the ICU, we enrolled consecutive patients older than 18 years expected to be in the ICU for more than 72 hours. Exclusion criteria were an admitting diagnosis of trauma, orthopedic surgery or cardiac surgery, pregnancy, and life support withdrawal. Patients had platelet counts performed as directed by clinical need. We defined thrombocytopenia as a platelet count of less than 150 × 10
9/L and severe thrombocytopenia as a platelet count of less than 50 × 10
9/L. Protocol-directed care included routine thromboprophylaxis and twice weekly screening ultrasonography of the legs. Patients were followed to hospital discharge.
Of the 261 enrolled patients, 121 (46%, 95% confidence interval CI, 40%-53%) had thrombocytopenia (62 on ICU admission and 59 acquired during their ICU stay). Patients who developed a platelet count less than 150 × 10
9/L during their ICU stay had higher ICU and hospital mortality (
P = .03 and .005, respectively), required longer mechanical ventilation (
P = .05), and were more likely to receive platelets (
P < .001), fresh frozen plasma (
P = .005), and red blood cell transfusions (
P = .004) than patients who did not develop thrombocytopenia. The only independent risk factors for thrombocytopenia developing during the ICU stay were administration of nonsteroidal anti-inflammatory drugs before ICU admission (hazard ratio, 2.8; 95% CI, 1.3-6.0) and dialysis during the ICU stay (hazard ratio, 3.1; 95% CI, 1.2-7.8). Of the 33 patients who underwent 36 tests for heparin-induced thrombocytopenia, none tested positive.
We found that about 50% of the patients admitted to the ICU had at least one platelet count of less than 150 × 10
9/L during their ICU stay. Patients who developed thrombocytopenia were more likely to die, required longer duration of mechanical ventilation, and were more likely to require blood product transfusion. Heparin-induced thrombocytopenia was frequently suspected but did not develop in these critically ill patients.
Prone ventilation (PV) is a ventilatory strategy that frequently improves oxygenation and lung mechanics in critical illness, yet does not consistently improve survival. While the exact physiologic ...mechanisms related to these benefits remain unproven, one major theoretical mechanism relates to reducing the abdominal encroachment upon the lungs. Concurrent to this experience is increasing recognition of the ubiquitous role of intra-abdominal hypertension (IAH) in critical illness, of the relationship between IAH and intra-abdominal volume or thus the compliance of the abdominal wall, and of the potential difference in the abdominal influences between the extrapulmonary and pulmonary forms of acute respiratory distress syndrome. The present paper reviews reported data concerning intra-abdominal pressure (IAP) in association with the use of PV to explore the potential influence of IAH. While early authors stressed the importance of gravitationally unloading the abdominal cavity to unencumber the lung bases, this admonition has not been consistently acknowledged when PV has been utilized. Basic data required to understand the role of IAP/IAH in the physiology of PV have generally not been collected and/or reported. No randomized controlled trials or meta-analyses considered IAH in design or outcome. While the act of proning itself has a variable reported effect on IAP, abundant clinical and laboratory data confirm that the thoracoabdominal cavities are intimately linked and that IAH is consistently transmitted across the diaphragm--although the transmission ratio is variable and is possibly related to the compliance of the abdominal wall. Any proning-related intervention that secondarily influences IAP/IAH is likely to greatly influence respiratory mechanics and outcomes. Further study of the role of IAP/IAH in the physiology and outcomes of PV in hypoxemic respiratory failure is thus required. Theories relating inter-relations between prone positioning and the abdominal condition are presented to aid in designing these studies.
Purpose
Existing clinical practice guidelines support the use of neuromuscular blocking agents (NMBA) in acute respiratory distress syndrome (ARDS); however, a recent large randomized clinical trial ...(RCT) has questioned this practice. Therefore, we updated a previous systematic review to determine the efficacy and safety of NMBAs in ARDS.
Methods
We searched MEDLINE, EMBASE (October 2012 to July 2019), the Cochrane (Central) database, and clinical trial registries (
ClinicalTrials.gov
, ISRCTN Register, and WHO ICTRP) for RCTs comparing the effects of NMBA as a continuous infusion versus placebo or no NMBA infusion (but allowing intermittent NMBA boluses) on patient-important outcomes for adults with ARDS. Two independent reviewers assessed the methodologic quality of the primary studies and abstracted data.
Results
Seven RCTs, including four new RCTs, met eligibility criteria for this review. These trials enrolled 1598 patients with moderate to severe ARDS at centers in the USA, France, and China. All trials assessed short-term continuous infusions of cisatracurium or vecuronium. The pooled estimate for mortality outcomes showed significant statistical heterogeneity, which was only explained by a subgroup analysis by depth of sedation in the control arm. A continuous NMBA infusion did not improve mortality when compared to a light sedation strategy with no NMBA infusion (relative risk RR 0.99; 95% CI 0.86–1.15; moderate certainty;
P =
0.93). On the other hand, continuous NMBA infusion reduced mortality when compared to deep sedation with as needed NMBA boluses (RR 0.71; 95% CI 0.57–0.89; low certainty;
P =
0.003). Continuous NMBA infusion reduced the rate of barotrauma (RR 0.55; 95% CI 0.35–0.85, moderate certainty;
P
= 0.008) across eligible trials, but the effect on ventilator-free days, duration of mechanical ventilation, and ICU-acquired weakness was uncertain.
Conclusions
Inconsistency in study methods and findings precluded the pooling of all trials for mortality. In a pre-planned sensitivity analysis, the impact of NMBA infusion on mortality depends on the strategy used in the control arm, showing reduced mortality when compared to deep sedation, but no effect on mortality when compared to lighter sedation. In both situations, a continuous NMBA infusion may reduce the risk of barotrauma, but the effects on other patient-important outcomes remain unclear. Future research, including an individual patient data meta-analysis, could help clarify some of the observed findings in this updated systematic review.
OBJECTIVES:Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many ...patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials.
DESIGN:Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003.
SETTING:Randomized clinical trials involving patients in an acute or nonacute care setting.
SUBJECTS AND INTERVENTIONS:We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators.
MEASUREMENTS AND MAIN RESULTS:Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72–9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size.
CONCLUSIONS:Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.
IntroductionIn donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain ...activity. While this assumption is rooted a strong physiological rationale, paucity of direct human data regarding temporal relationship between cessation of brain activity and circulatory arrest during the dying process threatens public and healthcare provider trust in deceased organ donation.Methods and analysisIn this cohort study, we will prospectively record cerebral and brainstem electrical activity, cerebral blood flow velocity and arterial blood pressure using electroencephalography (EEG), brainstem evoked potentials, transcranial doppler and bedside haemodynamic monitors in adult patients undergoing planned withdrawal of life sustaining measures in the intensive care units at five hospital sites for 18 months. We will use MATLAB to synchronise waveform data and compute the time of cessation of each signal relative to circulatory arrest. Our primary outcome is the feasibility of patient accrual, while secondary outcomes are (a) proportion of patients with complete waveform recordings and data transfer to coordinating site and (b) time difference between cessation of neurophysiological signals and circulatory arrest. We expect to accrue 1 patient/site/month for a total of 90 patients.Ethics and disseminationWe have ethics approval from Clinical Trials Ontario (protocol #3862, version 1.0, date 19 January 2022.) and the relevant Research Ethics Board for each site. We will obtain written informed consent from legal substitute decision makers. We will present study results at research conferences including donor family partner forum and in peer-reviewed publications.Trial registration numberNCT05306327.
OBJECTIVE:Certain methodologic features of animal experiments such as random assignment have been found to reduce the risk of bias. Because animal research sometimes informs clinical practice, ...explicit acknowledgment of the risk of bias and clinical relevance cultivates realistic expectations on the part of clinicians reading preclinical studies. We assessed literature reviews of therapeutic interventions for sepsis that include animal experiments for explicit appraisals of the risk of bias and clinical relevance.
DATA SOURCES:MEDLINE and EMBASE.
STUDY SELECTION:Systematic reviews or meta-analyses of animal experiments focusing on therapeutic interventions for sepsis.
DATA EXTRACTION:In teams of two, reviewers independently screened citations and abstracted data. We determined whether the reviews systematically incorporated critical appraisals for the risk of bias and clinical relevance of the underlying studies as well as explicit extrapolations from preclinical research to human patients.
DATA SYNTHESIS:From 164 citations, we retained 45 reviews. Chance-corrected agreement for inclusion was moderate (κ 0.57). Three (7%) met our criteria for a systematic review and one (2%) systematically appraised the risk of bias and the clinical relevance of the primary animal experiments. Thirty-six (80%) were narrative reviews addressing issues related to diverse topics such as pathophysiology and diagnosis as well as multiple therapies and 40 of 45 (89%) included both clinical and animal studies. Twelve (27%) explicitly assumed that data from preclinical studies could apply to human patients.
CONCLUSIONS:Although a significant proportion of reviews extrapolated preclinical study results to human patients, most did not systematically appraise the risk of bias or the clinical relevance of preclinical research. Because animal experiments may influence clinical practice, we propose a framework to enhance these features in future reviews of preclinical research.
High frequency oscillation is an alternative to conventional mechanical ventilation that is sometimes used to treat patients with acute respiratory distress syndrome, but effects on oxygenation, ...mortality and adverse clinical outcomes are uncertain. This review was originally published in 2004 and was updated in 2011.
To determine clinical and physiological effects of high frequency oscillation (HFO) in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) compared to conventional ventilation.
We electronically searched CENTRAL (Ovid), MEDLINE (Ovid), EMBASE (Ovid), and ISI (from inception to March 2011). The original search was performed in 2002. We manually searched reference lists from included studies and review articles; searched conference proceedings of the American Thoracic Society (1994 to 2010), Society of Critical Care Medicine (1994 to 2010), European Society of Intensive Care Medicine (1994 to 2010), and American College of Chest Physicians (1994 to 2010); contacted clinical experts in the field; and searched for unpublished and ongoing trials in clinicaltrials.gov and controlled-trials.com.
Randomized controlled clinical trials comparing treatment using HFO with conventional mechanical ventilation for children and adults diagnosed with ALI or ARDS.
Three authors independently extracted data on clinical, physiological, and safety outcomes according to a predefined protocol. We contacted investigators of all included studies to clarify methods and obtain additional data. We used random-effects models in the analyses.
Eight RCTs (n = 419) were included; almost all patients had ARDS. The risk of bias was low in six studies and unclear in two studies. The quality of evidence for hospital and six-month mortality was moderate and low, respectively. The ratio of partial pressure of oxygen to inspired fraction of oxygen at 24, 48, and 72 hours was 16% to 24% higher in patients receiving HFO. There were no significant differences in oxygenation index because mean airway pressure rose by 22% to 33% in patients receiving HFO (P < 0.01). In patients randomized to HFO, mortality was significantly reduced (RR 0.77, 95% CI 0.61 to 0.98; P = 0.03; 6 trials, 365 patients, 160 deaths) and treatment failure (refractory hypoxaemia, hypercapnoea, hypotension, or barotrauma) was less likely (RR 0.67, 95% CI 0.46 to 0.99; P = 0.04; 5 trials, 337 patients, 73 events). Other risks, including adverse events, were similar. We found substantial between-trial statistical heterogeneity for physiological (I(2) = 21% to 95%) but not clinical (I(2) = 0%) outcomes. Pooled results were based on few events for most clinical outcomes.
The findings of this systematic review suggest that HFO was a promising treatment for ALI and ARDS prior to the uptake of current lung protective ventilation strategies. These findings may not be applicable with current conventional care, pending the results of large multi-centre trials currently underway.
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