Gilles L Fraser

Maine Medical Center, Portland, Maine, United States

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Publications (76)469.4 Total impact

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    ABSTRACT: Enteral clonidine represents a potentially less costly alternative to dexmedetomidine for sedation in intensive care unit (ICU) patients. This study describes our practice of transitioning selected adult ICU patients from dexmedetomidine to clonidine with a focus on efficacy, safety, and drug acquisition costs. We conducted a single-center prospective observational pilot study from January through March 2014. Consecutive patients 18 years and older treated with dexmedetomidine and transitioned to clonidine were followed. The transition was assessed in five phases: dexmedetomidine maintenance, transition, clonidine maintenance, clonidine taper, and post clonidine. Efficacy data included any occurrence of significant pain, excessive agitation or oversedation, delirium, and need for ancillary psychoactive medications. Safety data included any occurrence of bradycardia, hypotension, new second- or third-degree atrioventricular node blockade, and clonidine withdrawal syndrome. Drug acquisition cost avoidances were estimated using average wholesale price. Twenty patients were evaluated. Fifteen (75%) were successfully transitioned from dexmedetomidine within 48 hours of starting clonidine. The initial and maintenance clonidine regimens were 0.3 mg every 6 hours. Clonidine was the sole α2A -receptor agonist administered for 45 hours while in the ICU and for 54 hours outside the ICU. Fentanyl requirements were lower when clonidine was administered as the sole α2A -receptor agonist as compared to dexmedetomidine alone (387 vs. 891 μg/day, p = 0.03). Otherwise, there were no statistically significant differences in efficacy data during the dexmedetomidine and clonidine maintenance phases. No statistically significant differences in safety data were observed. Clonidine withdrawal syndrome criteria were met in one patient. The potential drug acquisition cost avoidance was $819-$2338 per patient during the 3-month study. Transitioning from dexmedetomidine to clonidine may be an efficacious, safe, and less costly method of maintaining α2A -receptor agonist therapy in critically ill adults; these results warrant confirmation in expanded studies. © 2015 Pharmacotherapy Publications, Inc.
    Pharmacotherapy 03/2015; 35(3):251-9. DOI:10.1002/phar.1559 · 2.20 Impact Factor
  • Gilles L Fraser, David J Gagnon, Richard R Riker
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    ABSTRACT: Prophylactic antibiotics (PRO) reduce the incidence of early-onset pneumonia in comatose patients with structural brain injury, but have not been examined in cardiac arrest survivors undergoing targeted temperature management (TTM). We investigated the effect of PRO on the development of pneumonia in that population. We conducted a retrospective cohort study comparing patients treated with PRO to those not receiving PRO (no-PRO) using Northern Hypothermia Network registry data. Cardiac arrest survivors ≥ 18 years old with a GCS<8 at hospital admission and treated with TTM at 32-34°C were enrolled. Differences were analyzed in univariate analyses and with logistic regression models to evaluate independent associations of clinical factors with incidence of pneumonia and good functional outcome. 416 of 1,240 patients (34.5%) received PRO. Groups were similar in age, gender, arrest location, initial rhythm, and time from collapse to return of spontaneous circulation. PRO patients had less pneumonia (12.6% vs. 54.9%, p<0.001) and less sepsis (1.2% vs. 5.7%, p<0.001) compared to no-PRO patients. ICU length of stay (98 vs. 100hours, p=0.2) and incidence of a good functional outcome (41.1% vs. 36.6%, p=0.19) were similar between groups. Backwards stepwise logistic regression demonstrated PRO were independently associated with a lower incidence of pneumonia (OR 0.09, 95% 0.06-0.14, p<0.001) and a similar incidence of good functional outcome. Prophylactic antibiotics were associated with a reduced incidence of pneumonia but a similar rate of good functional outcome. Copyright © 2015. Published by Elsevier Ireland Ltd.
    Resuscitation 02/2015; DOI:10.1016/j.resuscitation.2015.01.035 · 3.96 Impact Factor
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    ABSTRACT: Purpose Non-benzodiazepine (BZ) sedation (e.g. dexmedetomidine or propofol) may be more cost-effective (CE) than BZ sedation despite its higher acquisition cost. Materials and Methods A CE analysis of non-cardiac surgery, critically ill adults requiring ≥ 1 d of mechanical ventilation (MV) and administered either BZ or non-BZ sedation, that cycled health states and costs daily using a Markov model accounting for daily MV use until ICU discharge, was conducted from a third-party perspective. Transition probabilities were obtained from a published meta-analysis and costs were estimated from best evidence. Sensitivity analyses were run for all extubation and discharge probabilities, for different cost estimates and for the specific non-BZ administered. Results When non-BZ rather than BZ sedation was used, the incremental CE ratio (ICER) to avert 1 ICU day while MV, or while either MV or non-MV, was $3,406 and $3,136, respectively. The base-case analysis revealed that non-BZ sedation (vs. BZ sedation) resulted in higher drug costs ($1,327 vs. $65) but lower total ICU costs (% accounted for MV need): $35,380 (71.0%) vs. $45,394 (70.6%). Sensitivity analysis revealed that BZ sedation would only be less costly if the daily rate of extubation was ≥ 16% and the daily rate of ICU discharge without MV was ≥ 77%. The ICER to avert 1 ICU day while MV or non-MV was similar between the dexmedetomidine and propofol non-BZ options. Conclusions Among MV adults, non-BZ sedation has a more favorable CE ratio than BZ sedation over most cost estimates.
    Journal of Critical Care 10/2014; 29(5). DOI:10.1016/j.jcrc.2014.05.020 · 2.19 Impact Factor
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    ABSTRACT: Introduction Triage after resuscitation from cardiac arrest is hindered by reliable early estimation of brain injury. We evaluated the performance of a triage model based on early bispectral index (BIS) findings and cardiac risk classes. Methods Retrospective evaluation of serial patients resuscitated from cardiac arrest, unable to follow commands, and undergoing hypothermia. Patients were assigned to a cardiac risk group: STEMI, VT/VF shock, VT/VF no shock, or PEA/asystole, and to a neurological dysfunction group, based on the BIS score following first neuromuscular blockade (BISi), and classified as BISi > 20, BISi 10-20, or BISi < 10. Cause of death was described as neurological or circulatory. Results BISi in 171 patients was measured at 267(±177) minutes after resuscitation and 35(±1.7)°C. BISi < 10 suffered 82% neurological-cause and 91% overall mortality, BISi 10-20 35% neurological and 55% overall mortality, and BISi > 20 12% neurological and 36% overall mortality. 33 patients presented with STEMI, 15 VT/VF-shock, 41 VT/VF-no shock, and 80 PEA/asystole. Among BISi > 20 patients, 75% with STEMI underwent urgent cardiac catheterization (cath) and 94% had good outcome. When BISi > 20 with VT/VF and shock, urgent cath was infrequent (33%), and 4 deaths (44%) were uniformly of circulatory etiology. Of 56 VT/VF patients without STEMI, 24 were BISi > 20 but did not undergo urgent cath - 5(20.8%) of these had circulatory-etiology death. Circulatory-etiology death also occurred in 26.5% BIS > 20 patients with PEA/asytole. When BISi < 10, a neurological etiology death dominated independent of cardiac risk group. Conclusions Neurocardiac triage based on very early processed EEG (BIS) is feasible, and may identify patients appropriate for individualized post-resuscitation care. This and other triage models warrant further study.
    Resuscitation 08/2014; 85(8). DOI:10.1016/j.resuscitation.2014.04.016 · 3.96 Impact Factor
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    ABSTRACT: Background Sedation and analgesia regimens during targeted temperature management (TTM), after cardiac arrest varies widely, are poorly described in the literature and may have a negative impact on outcome. Since implementing TTM in 2005, we have used moderate-dose sedation and describe our experience with this approach. Methods In this retrospective review, we included patients treated with TTM for cardiac arrest at our institution for 2008–2012. Patients received TTM if they did not follow verbal commands following cardiac arrest, regardless of place of arrest or rhythm. Utstein-compatible data were prospectively entered into the International Cardiac Arrest Registry, supplemented by review of nursing, pharmacy, and physical therapy records. We report analgesic and sedative medications and doses during the 24 h of active TTM at 33 °C, resource utilization, and important clinical events. Results 166 patients treated with TTM after in- and out-of-hospital cardiac arrest with complete data were included. Overall survival was 42 %, median time to following commands was 3 h after rewarming (–6, 14), time to spontaneous breathing trial was 19 h (5–35), time to extubation was 28 h (9–60), and 59 % of survivors were discharged directly home at 13 (10–20) days. The incidence of seizure was 6 %, septic shock 4 %, and pneumonia 32 %. Four survivors required tracheostomy at 8, 8, 12, and 16 days. Conclusions A moderate-dose sedation and analgesia regimen was well tolerated and effective during therapeutic hypothermia after cardiac arrest and is an effective alternative to very deep sedation. We recommend more complete description of sedation and analgesia protocols in future studies, including expanded outcome reporting to include variables affected by sedation therapy. Further study is required to define which sedation approach for TTM may be best.
    Neurocritical Care 06/2014; 22(1). DOI:10.1007/s12028-014-9998-3 · 2.60 Impact Factor
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    ABSTRACT: We reviewed randomized trials of adult ICU patients of interventions hypothesized to reduce delirium burden to determine whether interventions that are more effective at reducing delirium duration are associated with a reduction in short-term mortality. We searched CINHAHL, EMBASE, MEDLINE, and the Cochrane databases from 2001 to 2012. Citations were screened for randomized trials that enrolled critically ill adults, evaluated delirium at least daily, compared a drug or nondrug intervention hypothesized to reduce delirium burden with standard care (or control), and reported delirium duration and/or short-term mortality (≤ 45 d). In duplicate, we abstracted trial characteristics and results and evaluated quality using the Cochrane risk of bias tool. We performed random effects model meta-analyses and meta-regressions. We included 17 trials enrolling 2,849 patients which evaluated a pharmacologic intervention (n = 13) (dexmedetomidine [n = 6], an antipsychotic [n = 4], rivastigmine [n = 2], and clonidine [n = 1]), a multimodal intervention (n = 2) (spontaneous awakening [n = 2]), or a nonpharmacologic intervention (n = 2) (early mobilization [n = 1] and increased perfusion [n = 1]). Overall, average delirium duration was lower in the intervention groups (difference = -0.64 d; 95% CI, -1.15 to -0.13; p = 0.01) being reduced by more than or equal to 3 days in three studies, 0.1 to less than 3 days in six studies, 0 day in seven studies, and less than 0 day in one study. Across interventions, for 13 studies where short-term mortality was reported, short-term mortality was not reduced (risk ratio = 0.90; 95% CI, 0.76-1.06; p = 0.19). Across 13 studies that reported mortality, meta-regression revealed that delirium duration was not associated with reduced short-term mortality (p = 0.11). A review of current evidence fails to support that ICU interventions that reduce delirium duration reduce short-term mortality. Larger controlled studies are needed to establish this relationship.
    Critical care medicine 02/2014; 42(6). DOI:10.1097/CCM.0000000000000224 · 6.15 Impact Factor
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    ABSTRACT: To the Editor: In the study describing neurocognitive outcomes in patients in intensive care units (ICUs) reported by Pandharipande et al. (Oct. 3 issue),(1) patients with Richmond Agitation-Sedation Scale (RASS) scores of -3 (movement or eye opening to voice but no eye contact) or higher were assessed daily for delirium. (Scores on the RASS range from -5 to 4, with lower scores indicating less arousal, higher scores indicating more agitation, and O indicating an alert and calm state.) Recent data strongly suggest that sedation confounds delirium assessment, especially with the Confusion Assessment Method for the ICU (CAM-ICU), in which the . . .
    New England Journal of Medicine 01/2014; 370(2):184-186. DOI:10.1056/NEJMc1313886#SA1 · 54.42 Impact Factor
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    European Journal of Intensive Care Medicine 10/2013; 39(12). DOI:10.1007/s00134-013-3105-7 · 5.54 Impact Factor
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    ABSTRACT: Background: Use of dexmedetomidine or propofol rather than a benzodiazepine sedation strategy may improve ICU outcomes. We reviewed randomized trials comparing a benzodiazepine and nonbenzodiazepine regimen in mechanically ventilated adult ICU patients to determine if differences exist between these sedation strategies with respect to ICU length of stay, time on the ventilator, delirium prevalence, and short-term mortality. Methods: We searched CINAHL, MEDLINE, the Cochrane databases, and the American College of Critical Care Medicine’s Pain, Agitation, Delirium Management Guidelines’ literature database from 1996 to 2013. Citations were screened for randomized trials that enrolled critically ill, mechanically ventilated adults comparing an IV benzodiazepine-based to a nonbenzodiazepine-based sedative regimen and reported duration of ICU length of stay, duration of mechanical ventilation, delirium prevalence, and/or short-term mortality. Trial characteristics and results were abstracted in duplicate and independently, and the Cochrane risk of bias tool was used for quality assessment. We performed random effects model meta-analyses where possible. Results: We included six trials enrolling 1,235 patients: midazolam versus dexmedetomidine (n = 3), lorazepam versus dexmedetomidine (n = 1), midazolam versus propofol (n = 1), and lorazepam versus propofol (n = 1). Compared to a benzodiazepine sedative strategy, a nonbenzodiazepine sedative strategy was associated with a shorter ICU length of stay (n = 6 studies; difference = 1.62 d; 95% CI, 0.68–2.55; I2 = 0%; p = 0.0007) and duration of mechanical ventilation (n = 4 studies; difference = 1.9 d; 95% CI, 1.70–2.09; I2 = 0%; p < 0.00001) but a similar prevalence of delirium (n = 2; risk ratio = 0.83; 95% CI, 0.61–1.11; I2 = 84%; p = 0.19) and short-term mortality rate (n = 4; risk ratio = 0.98; 95% CI, 0.76–1.27; I2 = 30%; p = 0.88). Conclusions: Current controlled data suggest that use of a dexmedetomidine- or propofol-based sedation regimen rather than a benzodiazepine-based sedation regimen in critically ill adults may reduce ICU length of stay and duration of mechanical ventilation. Larger controlled studies are needed to further define the impact of nonbenzodiazepine sedative regimens on delirium and short-term mortality.
    Critical Care Medicine 09/2013; 41(9):S30-S38. DOI:10.1097/CCM.0b013e3182a16898 · 6.15 Impact Factor
  • Gilles L Fraser, Craig P Worby, Richard R Riker
    Critical care medicine 04/2013; 41(4):1144-6. DOI:10.1097/CCM.0b013e31827c02f0 · 6.15 Impact Factor
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    ABSTRACT: Although pharmacotherapy remains the mainstay for the prevention and treatment of pain, anxiety, and delirium (PAD) in the intensive care unit (ICU), many of the PAD-related medications currently used may lead to unintended consequences, particularly when these agents are administered at excessive doses for prolonged periods. The method by which these medications are administered and titrated is increasingly being recognized as potentially affecting patient outcomes as much as the drug itself. Drugs once thought to have a pharmacologically desirable profile in reducing PAD have been shown to have either little benefit, the potential for significant risk associated with any benefit, or in some cases, the potential to worsen patient outcome. The recently published American College of Critical Care Medicine (ACCM) Pain, Agitation, and Delirium Clinical Practice Guidelines provide 12 medication-related recommendations surrounding the prevention and treatment of PAD. This paper (1) provides the ICU bedside clinician with more background on the most important, and in some cases most contentious and challenging areas, of sedation and delirium pharmacotherapy in the critical care setting; (2) provides an update on the most recent evidence surrounding the prevention and treatment of agitation and delirium in ICU; and (3) highlights areas that require further investigation and provide practical strategies by which to apply current evidence in this area to daily ICU practice.
    Seminars in Respiratory and Critical Care Medicine 04/2013; 34(2):201-215. DOI:10.1055/s-0033-1342983 · 3.02 Impact Factor
  • Richard R Riker, Gilles L Fraser
    American Journal of Critical Care 03/2013; 22(2):153-7. DOI:10.4037/ajcc2013480 · 1.60 Impact Factor
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    ABSTRACT: OBJECTIVE:: Retrospective analyses of several trials suggest etomidate may be unsafe for intubation in patients with sepsis. We evaluated the association of etomidate and mortality in a large cohort of septic patients to determine if single-dose etomidate was associated with increased in-hospital mortality. DESIGN AND SETTING:: Retrospective cohort study at the Philips eICU Research Institute ICU clinical database. INTERVENTIONS:: None. PATIENTS:: Among 741,036 patients monitored from 2008 through 2010, we identified 2,014 adults intubated in the ICU 4-96 hrs after admission, having clinical criteria consistent with sepsis, severe sepsis, or septic shock. In all, 1,102 patients received etomidate and 912 received other induction agents for intubation. MEASUREMENTS AND MAIN RESULTS:: The primary endpoint was in-hospital mortality, but we also evaluated demographic and clinical factors, severity of illness, ICU mortality, ICU length of stay, hospital length of stay, ventilator days, and vasopressor days. Competing risk Cox proportional hazard regression models were used for primary outcomes. Demographics and illness severity were similar between the groups. Hospital mortality was similar between the groups (37.2% vs. 37.8%, p = 0.77), as were ICU mortality (30.1% vs. 30.2%, p = 0.99), ICU length of stay (8.7 days vs. 8.9 days, p = 0.66), and hospital length of stay (15.2 vs. 14.6 days, p = 0.31). More patients in the etomidate group received steroids before and after intubation (52.9% vs. 44.5%, p < 0.001), but vasopressor use and duration of mechanical ventilation were similar. No regression model showed an independent association of etomidate with mortality, shock, duration of mechanical ventilation, ICU or hospital length of stay, or vasopressor use. A hospital mortality model limited to only patients with septic shock (n = 650) also showed no association of etomidate and hospital mortality. CONCLUSION:: In a mixed-diagnosis group of critically ill patients with sepsis, severe sepsis, and septic shock, single-dose etomidate administration for intubation in the ICU was not associated with higher mortality or other adverse clinical outcomes.
    Critical care medicine 01/2013; DOI:10.1097/CCM.0b013e318274190d · 6.15 Impact Factor
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    ABSTRACT: Objective To revise the "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult" published in Critical Care Medicine in 2002. Methods The American College of Critical Care Medicine assembled a 20-person, multidisciplinary, multi-institutional task force with expertise in guideline development, pain, agitation and sedation, delirium management, and associated outcomes in adult critically ill patients. The task force, divided into four subcommittees, collaborated over six years in person, via teleconferences, and via electronic communication. Subcommittees were responsible for developing relevant clinical questions, using the Grading of Recommendations Assessment, Development and Evaluation method (www.gradeworkinggroup.org) to review, evaluate, and summarize the literature, and to develop clinical statements (descriptive) and recommendations (actionable). With the help of a professional librarian and Refworks database software, they developed a Web-based electronic database of over 19,000 references extracted from eight clinical search engines, related to pain and analgesia, agitation and sedation, delirium, and related clinical outcomes in adult ICU patients. The group also used psychometric analyses to evaluate and compare pain, agitation/sedation, and delirium assessment tools. All task force members were allowed to review the literature supporting each statement and recommendation and provided feedback to the subcommittees. Group consensus was achieved for all statements and recommendations using the nominal group technique and the modified Delphi method, with anonymous voting by all task force members using E-Survey (www.esurvey.com). All voting was completed in December 2010. Relevant studies published after this date and prior to publication of these guidelines were referenced in the text. The quality of evidence for each statement and recommendation was ranked as high (A), moderate (B), or low/very low (C). The strength of recommendations was ranked as strong (1) or weak (2) and either in favor of (+) or against (-) an intervention. A strong recommendation (either for or against) indicated that the intervention's desirable effects either clearly outweighed its undesirable effects (risks, burdens, and costs) or it did not. For all strong recommendations, the phrase "We recommend..." is used throughout. A weak recommendation, either for or against an intervention, indicated that the tradeoff between desirable and undesirable effects was less clear. For all weak recommendations, the phrase "We suggest..." is used throughout. In the absence of sufficient evidence, or when group consensus could not be achieved, no recommendation (0) was made. Consensus based on expert opinion was not used as a substitute for a lack of evidence. A consistent method for addressing potential conflicts of interest was followed if task force members were coauthors of related research. The development of this guideline was independent of any industry funding. Conclusion These guidelines provide a roadmap for developing integrated, evidence-based, and patient-centered protocols for preventing and treating pain, agitation, and delirium in critically ill patients. Am J Health-Syst Pharm. 2013; 70:53-8.
    American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists 01/2013; 70(1):53-8. · 2.21 Impact Factor
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    ABSTRACT: OBJECTIVE:: To revise the "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult" published in Critical Care Medicine in 2002. METHODS:: The American College of Critical Care Medicine assembled a 20-person, multidisciplinary, multi-institutional task force with expertise in guideline development, pain, agitation and sedation, delirium management, and associated outcomes in adult critically ill patients. The task force, divided into four subcommittees, collaborated over 6 yr in person, via teleconferences, and via electronic communication. Subcommittees were responsible for developing relevant clinical questions, using the Grading of Recommendations Assessment, Development and Evaluation method (http://www.gradeworkinggroup.org) to review, evaluate, and summarize the literature, and to develop clinical statements (descriptive) and recommendations (actionable). With the help of a professional librarian and Refworks® database software, they developed a Web-based electronic database of over 19,000 references extracted from eight clinical search engines, related to pain and analgesia, agitation and sedation, delirium, and related clinical outcomes in adult ICU patients. The group also used psychometric analyses to evaluate and compare pain, agitation/sedation, and delirium assessment tools. All task force members were allowed to review the literature supporting each statement and recommendation and provided feedback to the subcommittees. Group consensus was achieved for all statements and recommendations using the nominal group technique and the modified Delphi method, with anonymous voting by all task force members using E-Survey (http://www.esurvey.com). All voting was completed in December 2010. Relevant studies published after this date and prior to publication of these guidelines were referenced in the text. The quality of evidence for each statement and recommendation was ranked as high (A), moderate (B), or low/very low (C). The strength of recommendations was ranked as strong (1) or weak (2), and either in favor of (+) or against (-) an intervention. A strong recommendation (either for or against) indicated that the intervention's desirable effects either clearly outweighed its undesirable effects (risks, burdens, and costs) or it did not. For all strong recommendations, the phrase "We recommend …" is used throughout. A weak recommendation, either for or against an intervention, indicated that the trade-off between desirable and undesirable effects was less clear. For all weak recommendations, the phrase "We suggest …" is used throughout. In the absence of sufficient evidence, or when group consensus could not be achieved, no recommendation (0) was made. Consensus based on expert opinion was not used as a substitute for a lack of evidence. A consistent method for addressing potential conflict of interest was followed if task force members were coauthors of related research. The development of this guideline was independent of any industry funding. CONCLUSION:: These guidelines provide a roadmap for developing integrated, evidence-based, and patient-centered protocols for preventing and treating pain, agitation, and delirium in critically ill patients.
    Critical care medicine 01/2013; 41(1):278-280. DOI:10.1097/CCM.0b013e3182783b72 · 6.15 Impact Factor
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    ABSTRACT: AIM: Patients sustain a range of neurologic injuries after cardiac arrest, and determining which patients should be treated with therapeutic hypothermia (TH) is complex, often confounded by sedation and neuromuscular blockade (NMB). We evaluated bispectral index (BIS) monitoring as a tool to identify adult patients that awakened during therapeutic hypothermia. METHODS: Review of prospectively collected registry data, with retrospective chart review of patient descriptions during hypothermia. Data are presented as median (interquartile range). RESULTS: 7 of 309 patients (2.2%) treated with TH over 6 years awoke (followed commands) prior to completing hypothermia. Median age was 58 (54-66) years; 71% were male, cardiac arrest was witnessed in 6 (86%) and out-of-hospital in 6 (86%), and 4 patients (57%) were transferred from another hospital. 5 patients (71%) had an initial rhythm of ventricular tachycardia or fibrillation, time to return of spontaneous circulation was 17 (12-23) minutes. The BIS value after first NMB dose during TH was 63, 45, 43, 52, 62, 54, and 42, (median 52, IQR 44-58, 95% confidence interval 46-58). The median BIS value in the remaining data set (n=302) was 18 (6-36), p<0.001, and only 6% of BIS1 values were >46. CONCLUSION: Patients who awakened early had higher BIS values after the first dose of NMB. Processed EEG values after cardiac arrest may provide additional information that could assist with determining best treatment.
    Resuscitation 10/2012; DOI:10.1016/j.resuscitation.2012.10.014 · 3.96 Impact Factor
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    ABSTRACT: Prothrombin complex concentrates (PCCs) offer a means for the rapid reversal of warfarin, particularly in the setting of life-threatening bleeding. We evaluated the effectiveness and safety of a PCC-based protocol in patients with warfarin-associated intracerebral hemorrhage (ICH), subdural hematoma (SDH), or subarachnoid hemorrhage (SAH). This was a retrospective case-series review of patients treated with an institution-approved warfarin reversal protocol. Patients with intracranial hemorrhage and known warfarin use with an international normalized ratio (INR)>1.4 received fresh frozen plasma (FFP), vitamin K (phytonadione), and weight-based, 3-factor PCC (Profilnine(®) SD) dose based on the initial INR. Demographic and clinical information, the degree of and time to INR normalization, and adverse events were recorded. The thirty study patients included 19 with primary ICH, 7 with SDH, and 4 with SAH. The mean age was 72.8 (±11) years, including 11 (37%) patients ≥80years old. The median presenting INR was 2.3 (IQR 2-3.3) and post-treatment INR was 1.4 (IQR 1.3-1.5, Z score 6.4, p<0.001). Median time from PCC administration to the first follow up INR was 95 (IQR 50-140) min. No patient's INR increased by more than 0.3 over 72h. Nine patients (30%) underwent neurosurgical procedures after PCC administration and no procedure-related bleeding complication was noted. Adverse events included 3 instances of early hematoma expansion, one ischemic stroke in a patient with endocarditis on post-PCC day 1, one pulmonary embolism 5weeks after PCC treatment, and one coronary in-stent thrombosis 60days after PCC treatment. 6 patients died prior to hospital discharge of anticipated complications of their initial event, and none from identifiable thrombotic complications of PCC. A 3-factor PCC preparation (Profilnine(®) SD), administered with FFP and vitamin K to patients with acute warfarin-associated intracranial bleeding is a reasonable approach to urgent warfarin reversal. However, randomized, prospective trials are needed to verify the safety and clinical effectiveness of PCC administration in this population.
    Clinical neurology and neurosurgery 07/2012; 115(6). DOI:10.1016/j.clineuro.2012.07.006 · 1.25 Impact Factor
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    Richard R Riker, Gilles L Fraser
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    ABSTRACT: Providing sedation and comfort for intensive care patients has evolved in the last 30 years but remains difficult for clinicians. As research has focused on this challenging area, the authors have identified ways to improve practice, including providing analgesia before sedation, strategies to help recognize dangerous adverse effects associated with the medications that are used, and better ways to monitor pain and delirium in patients. Dexmedetomidine and propofol have become the preferred sedatives for many ICU situations, and creative ways to administer them, such as linking awakening and breathing trials, are emerging. Finally, screening survivors for cognitive impairments may allow clinicians to refer them for the focused rehabilitation they require.
    Anesthesiology Clinics 12/2011; 29(4):663-74. DOI:10.1016/j.anclin.2011.09.006
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    ABSTRACT: To evaluate steady-state bivalirudin dosing requirements in patients with a wide range of kidney function who were being treated for heparin-induced thrombocytopenia (HIT)-related disorders. Retrospective medical record review. Academic medical center. Sixty-four adults with varying degrees of renal function who were receiving bivalirudin for at least 48 hours for HIT-related disorders between March 2007 and May 2010. Steady-state conditions were defined as a constant bivalirudin infusion dose for at least 12 hours, with serum creatinine concentration varying less than 20% for 48 hours (for patients not receiving renal replacement therapy) and at least two therapeutic activated partial thromboplastin time (aPTT) values (60-80 sec). Patients were assigned to five groups based on Cockcroft-Gault-estimated creatinine clearance (Clcr) of less than 30, 30-60, or greater than 60 ml/minute, or by type of renal replacement therapy-intermittent hemodialysis or continuous venovenous hemofiltration (CVVH). For Clcr greater than 60 ml/minute, the median bivalirudin dose was 0.15 mg/kg/hour (interquartile range [IQR] 0.11-0.15 mg/kg/hr), which was greater than median doses for Clcr 30-60 ml/minute (0.10 mg/kg/hr, IQR 0.06-0.13 mg/kg/hr, p=0.004), Clcr less than 30 ml/minute (0.08 mg/kg/hr, IQR 0.04-0.1 mg/kg/hr, p=0.001), CVVH (0.06 mg/kg/hr, IQR 0.03-0.10 mg/kg/hr, p=0.046), and hemodialysis (0.04 mg/kg/hr, IQR 0.03-0.05 mg/kg/hr, p=0.0001). Bivalirudin doses correlated with Clcr (Spearman r = 0.58, p<0.01). The median aPTT value of 70 seconds (IQR 63-74 sec) was similar in all groups. Thrombosis was present before bivalirudin therapy in 18 (28%) of 64 patients, and two patients (3%) developed thromboemboli during bivalirudin therapy. Clinically significant bleeding related to bivalirudin and leading to discontinuation of bivalirudin occurred in four patients (6%). The median international normalized ratio increased from 1.5 (IQR 1.3-1.7) before bivalirudin therapy to 1.9 (IQR 1.8-2.1) during bivalirudin therapy (p=0.002) in 11 patients who were not receiving warfarin. Bivalirudin dosing requirements increased with increasing Clcr values. The high degree of variability suggests that dosing in individual patients will require careful titration to achieve adequate anticoagulation.
    Pharmacotherapy 09/2011; 31(9):850-6. DOI:10.1592/phco.31.9.850 · 2.20 Impact Factor

Publication Stats

3k Citations
469.40 Total Impact Points

Institutions

  • 2000–2015
    • Maine Medical Center
      • • Department of Pharmacy
      • • Division of Infectious Diseases
      Portland, Maine, United States
  • 2011–2014
    • Tufts University
      Бостон, Georgia, United States
  • 2002–2007
    • University of Vermont
      • College of Medicine
      Burlington, Vermont, United States
  • 2001–2006
    • Burlington College
      Burlington, Vermont, United States