Neurocritical care
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One of the challenges in bringing new therapeutic agents (since nimodipine) in for the treatment of cerebral ischemia associated with aneurysmal subarachnoid hemorrhage (aSAH) is the incongruence in therapeutic benefit observed between phase II and subsequent phase III clinical trials. Therefore, identifying areas for improvement in the methodology and interpretation of results is necessary to increase the value of phase II trials. We performed a systematic review of phase II trials that continued into phase III trials, evaluating a therapeutic agent for the treatment of cerebral ischemia associated with aSAH. ⋯ Shortcomings in several design elements of the phase II aSAH trials were identified that may explain the incongruence between phase II and phase III trial results. We suggest the consideration of the following strategies to improve phase II design: increased focus on the selection of surrogate markers of efficacy, selection of the optimal dose and timing of intervention, adjustment for exaggerated estimate of treatment effect in sample size calculations, use of prespecified go/no-go criteria using futility design, use of multicenter design, enrichment of the study population, use of concurrent control or placebo group, and use of innovative trial designs such as seamless phase II to III design. Modifying the design of phase II trials on the basis of lessons learned from previous phase II and phase III trial combinations is necessary to plan more effective phase III trials.
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Observational Study
Pre Versus Post Implementation of a Pharmacologic Antishivering Protocol During Targeted Temperature Management Following Cardiac Arrest.
Targeted temperature management (TTM) is endorsed by various guidelines to improve neurologic outcomes following cardiac arrest. Shivering, a consequence of hypothermia, can counteract the benefits of TTM. Despite its frequent occurrence, consensus guidelines provide minimal guidance on the management of shivering. The purpose of this study was to evaluate the impact of a pharmacologic antishivering protocol in patients undergoing TTM following cardiac arrest on the incidence of shivering. ⋯ In patients undergoing TTM following cardiac arrest, the implementation of a pharmacologic antishivering protocol reduced the incidence of shivering and the use neuromuscular blocking agents. Prospective data are needed to validate the results and further evaluate the safety and efficacy of an antishivering protocol on clinical outcomes.
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Neurocritical care has advanced substantially in recent decades, allowing doctors to treat patients with more complicated conditions who require a multidisciplinary approach to achieve better clinical outcomes. In neurocritical patients, nonneurological complications such as acute kidney injury (AKI) are independent predictors of worse clinical outcomes. Different research groups have reported an AKI incidence of 11.6% and an incidence of stage 3 AKI, according to the Kidney Disease: Improving Global Outcomes, that requires dialysis of 3% to 12% in neurocritical patients. ⋯ This review will focus on AKI in neurocritical care patients. Specifically, it will discuss its epidemiology, causes, associated mechanisms, and relationship to the brain-kidney axis. Additionally, the use and risks of extracorporeal therapies in this group of patients will be reviewed.
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The 24-h head computed tomography (CT) scan following intravenous tissue plasminogen activator or mechanical thrombectomy (MT) is currently part of most acute stroke protocols. However, as evidence emerges regarding who is at highest risk for treatment complications, the utility of routine neuroimaging for all patients has become less clear. ⋯ The 24-h head CT scan does not change management for most patients, particularly those with low National Institutes of Health Stroke Scale scores who do not undergo MT. Consideration should be given to removing routine follow-up imaging from postthrombolysis protocols in favor of an examination-based approach.
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Randomized Controlled Trial
Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey.
In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects. ⋯ A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.