Judith Jacobi

Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult

Judith Jacobi, PharmD, FCCM, BCPS; Gilles L. Fraser, PharmD, FCCM; Douglas B. Coursin, MD; Richard R. Riker, MD; Dorrie Fontaine, RN, DNSc, FAAN; Eric T. Wittbrodt, PharmD; Donald B. Chalfin, MD, MS, FCCM; Michael F. Masica, MD, MPH; H. Scott Bjerke, MD; William M. Coplin, MD; David W. Crippen, MD, FCCM; Barry D. Fuchs, MD; Ruth M. Kelleher, RN; Paul E. Marik, MDBCh, FCCM; Stanley A. Nasraway, Jr, MD, FCCM; Michael J. Murray, MD, PhD, FCCM; William T. Peruzzi, MD, FCCM; Philip D. Lumb, MB, BS, FCCM. Developed through the Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), in collaboration with the American Society of Health-System Pharmacists (ASHP), and in alliance with the American College of Chest Physicians; and approved by the Board of Regents of ACCM and the Council of SCCM and the ASHP Board of Directors

Guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients.

Objective:To evaluate the literature and identify important aspects of insulin therapy that facilitate safe and effective infusion therapy for a defined glycemic end point. Methods:Where available, the literature was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology to assess the impact of insulin infusions on outcome for general intensive care unit patients and those in specific subsets of neurologic injury, traumatic injury, and cardiovascular surgery. Elements that contribute to safe and effective insulin infusion therapy were determined through literature review and expert opinion. The majority of the literature supporting the use of insulin infusion therapy for critically ill patients lacks adequate strength to support more than weak recommendations, termed suggestions, such that the difference between desirable and undesirable effect of a given intervention is not always clear. Recommendations:The article is focused on a suggested glycemic control end point such that a blood glucose ≥150 mg/dL triggers interventions to maintain blood glucose below that level and absolutely <180 mg/dL. There is a slight reduction in mortality with this treatment end point for general intensive care unit patients and reductions in morbidity for perioperative patients, postoperative cardiac surgery patients, post-traumatic injury patients, and neurologic injury patients. We suggest that the insulin regimen and monitoring system be designed to avoid and detect hypoglycemia (blood glucose ⩽70 mg/dL) and to minimize glycemic variability.Important processes of care for insulin therapy include use of a reliable insulin infusion protocol, frequent blood glucose monitoring, and avoidance of finger-stick glucose testing through the use of arterial or venous glucose samples. The essential components of an insulin infusion system include use of a validated insulin titration program, availability of appropriate staffing resources, accurate monitoring technology, and standardized approaches to infusion preparation, provision of consistent carbohydrate calories and nutritional support, and dextrose replacement for hypoglycemia prevention and treatment. Quality improvement of glycemic management programs should include analysis of hypoglycemia rates, run charts of glucose values <150 and 180 mg/dL. The literature is inadequate to support recommendations regarding glycemic control in pediatric patients. Conclusions:While the benefits of tight glycemic control have not been definitive, there are patients who will receive insulin infusion therapy, and the suggestions in this article provide the structure for safe and effective use of this therapy.

Sedation, analgesia, and neuromuscular blockade of the critically ill adult: Revised clinical practice guidelines for 2002

The critically ill and injured patient is invariably anxious, confused, uncomfortable, and in pain from immobility, wounds, and indwelling tubes and is generally distressed by the adverse environs of the intensive care unit. The restlessness associated with critical illness must nearly always, by necessity, be quelled with sedation and analgesia. Clinicians must sometimes use neuromuscular blockade as a last resort. The knowledge and practice of using sedatives, analgesics, and neuromuscular receptor blocking agents originated in and migrated out of the operating theater and postanesthesia recovery units. However, critical care clinicians have discovered that the sustained use of these agents in intensive care units has consequences that are different from those seen in the immediate perioperative period. The Society of Critical Care Medicine (SCCM) and the American College of Critical Care Medicine (ACCM) systematically reviewed, developed, and, in 1995, published clinical practice guidelines (CPGs) for sedation, analgesia, and neuromuscular blockade in the critically ill patient (1, 2). These CPGs are the most popular and requested of the SCCM and ACCM documents because of the complexities involved in achieving appropriate levels of sedation and analgesia without inducing complications. Recommendations stemming from the 1995 CPGs, although evidence based, were limited because of the lack of prospective randomized trials comparing agents. Since that time, new evidence has emerged and ACCM believes that the CPGs require updating. ACCM and SCCM have joined forces with the American Society of Health-System Pharmacists (ASHP) to develop new CPGs on the sustained use of sedatives, analgesics, and neuromuscular blocking agents in the critically ill adult (3, 4). The quality of care can be improved by implementing the best known and tested standards, measuring the consequences of what we do, and reducing variability found in practice through the use of protocols. CPGs, in tandem with protocol development, can serve as educational tools, improve outcomes, and reduce costs (5, 6). Evidence suggests that, in real practice, recommendations such as these are often not followed (7). “Clinical practice guidelines” are defined by the Institute of Medicine as “systematically developed statements to assist the practitioner and patient in decisions about appropriate health care for specific clinical circumstances” (8). Clinicians need to differentiate CPGs from a summary or review article (9–11). CPGs are vitally different from review articles and greatly valued for several reasons. Ideally, CPGs are created by a multidisciplinary task force of clinicians, including physicians, nurses, and pharmacists, as well as other health care professionals, under the auspices of the recommendations developed by critical evaluation of the graded scientific literature. CPGs are typically more comprehensive and far-reaching in scope than review articles and serve as virtual guiding lights by providing a useful construct of available evidence and expert decision-making against which individual decisions by clinicians and programs can be evaluated (12). A comprehensive literature search was performed to develop the CPGs. Published studies identified through a MEDLINE search (Sedation and Analgesia 1994 –2001; Neuromuscular blocking agents 1994–2001) were reviewed, as were the reference lists of the retrieved documents and abstracts from meetings of professional associations. The literature was critically evaluated for research design, patient selection, medication dose, administration route, combination treatment, test measures, statistics, and results. The medical literature ranged in quality from prospective randomized trials and retrospective observations to expert opinions (Table 1). Pertinent references were assigned a score to account for variance in quality. The recommendations of SCCM, ACCM, and ASHP (Joint Task Force) were graded according to the strength and quality of the scientific evidence (Table 2). A substantial effort was made by the Joint Task Force to adhere to the methodology for developing scientifically sound CPGs as prescribed by the American Medical Association, the Institute of Medicine, and the Canadian Medical Association (13–17). The 2002 clinical practice guidelines state the rationale, benefits, and harms of the recommendations, describe the expected health outcomes, and cite and rank the evidence. These CPGs will be reviewed and updated in three to five years. There are major additions, besides the updating of the science, to the 2001 CPGs being issued by the Joint Task Force (3, 4), compared with the 1995 guidelines. These guidelines are the most comprehensive documents in the fields of sedation, analgesia, and neuromuscular Address correspondence to Dr. Nasraway, Jr. at Tufts University School of Medicine, Department of Surgery, Tufts-New England Medical Center, 750 Washington Street, Box 4630, Boston, MA 02111 (snasraway@lifespan.org). Copyright

Prioritizing the organization and management of intensive care services in the United States: The PrOMIS Conference

Objective:Adult critical care services are a large, expensive part of U.S. health care. The current agenda for response to workforce shortages and rising costs has largely been determined by members of the critical care profession without input from other stakeholders. We sought to elicit the perceived problems and solutions to the delivery of critical care services from a broad set of U.S. stakeholders. Design:A consensus process involving purposive sampling of identified stakeholders, preconference Web-based survey, and 2-day conference. Setting:Participants represented healthcare providers, accreditation and quality-oversight groups, federal sponsoring institutions, healthcare vendors, and institutional and individual payers. Subjects:We identified 39 stakeholders for the field of critical care medicine. Thirty-six (92%) completed the preconference survey and 37 (95%) attended the conference. Interventions:None. Measurements and Main Results:Participants expressed moderate to strong agreement with the concerns identified by the critical care professionals and additionally expressed consternation that the critical care delivery system was fragmented, variable, and not patient-centered. Recommended solutions included regionalizing the adult critical care system into “tiers” defined by explicit triage criteria and professional competencies, achieved through voluntary hospital accreditation, supported through an expanded process of competency certification, and monitored through process and outcome surveillance; implementing mechanisms for improved communication across providers and settings and between providers and patients/families; and conducting market research and a public education campaign regarding critical care’s promises and limitations. Conclusions:This consensus conference confirms that agreement on solutions to complex healthcare delivery problems can be achieved and that problem and solution frames expand with broader stakeholder participation. This process can be used as a model by other specialties to address priority setting in an era of shifting demographics and increasing resource constraints.

The effect of selenium therapy on mortality in patients with sepsis syndrome: a systematic review and meta-analysis of randomized controlled trials.

Background:Patients with sepsis syndrome commonly have low serum selenium levels. Several randomized controlled trials have examined the efficacy of selenium supplementation on mortality in patients with sepsis. Objective:To determine the efficacy and safety of high-dose selenium supplementation compared to placebo for the reduction of mortality in patients with sepsis. Sources of Data:We searched Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, SciFinder, and Clinicaltrials.gov. Selection Criteria:Randomized controlled parallel group trials comparing selenium supplementation in doses greater than daily requirement to placebo on the outcome of mortality in patients with sepsis syndrome. Data Collection and Analysis:Two reviewers independently applied eligibility criteria, assessed quality, and extracted data. The primary outcome was mortality; secondary outcomes were ICU length of stay, nosocomial pneumonia, and adverse events. Trial authors were contacted for additional or clarifying information. Results:Nine trials enrolling a total of 792 patients were included. Selenium supplementation in comparison to placebo was associated with lower mortality (odds ratio, 0.73; 95% CI, 0.54, 0.98; p = 0.03; I2 = 0%). Among patients receiving and not receiving selenium, there was no difference in ICU length of stay (mean difference, 2.03; 95% CI, –0.51, 4.56; p = 0.12; I2 = 0%) or nosocomial pneumonia (odds ratio, 0.83; 95% CI, 0.28, 2.49; p = 0.74; I2 = 56%). Significant heterogeneity among trials in adverse event reporting precluded pooling of results. Conclusions:In patients with sepsis, selenium supplementation at doses higher than daily requirement may reduce mortality. We observed no impact of selenium on ICU length of stay or risk of nosocomial pneumonia.

Adverse drug events in intensive care units: risk factors, impact, and the role of team care.

Advances in diagnostic tests, technological interventions, and pharmacotherapy have resulted in spectacular results for many intensive care unit (ICU) patients who, in earlier generations, would have succumbed to their critical illness. At the same time, the complexity and intensity of care required for ICU patients is also associated with greater risks for harm resulting from care. As in other inpatient areas, medications are the most common type of therapy in ICUs and are also associated with the most frequent type of ICU adverse events. Critically ill patients are at high risk for adverse drug events for many reasons, including the complexity of their disease that creates challenges in drug dosing, their vulnerability to rapid changes in pharmacotherapy, the intensive care environment providing ample distractions and opportunity for error, the administration of complex drug regimens, the numerous high-alert medications that they receive, and the mode of drug administration. The clinical outcomes of adverse drug events can result in end-organ damage and even death. The costs of an adverse drug event can be substantial to healthcare systems with an additional

The Research Agenda in ICU Telemedicine: A Statement From the Critical Care Societies Collaborative

6,000–

The critical care clinical pharmacist: evolution of an essential team member.

9,000 for each event. The multiprofessional patient care team is one approach to promoting patient safety in the ICU.

Computerized intensive insulin dosing can mitigate hypoglycemia and achieve tight glycemic control when glucose measurement is performed frequently and on time

ICU telemedicine uses audiovisual conferencing technology to provide critical care from a remote location. Research is needed to best define the optimal use of ICU telemedicine, but efforts are hindered by methodological challenges and the lack of an organized delivery approach. We convened an interdisciplinary working group to develop a research agenda in ICU telemedicine, addressing both methodological and knowledge gaps in the field. To best inform clinical decision-making and health policy, future research should be organized around a conceptual framework that enables consistent descriptions of both the study setting and the telemedicine intervention. The framework should include standardized methods for assessing the preimplementation ICU environment and describing the telemedicine program. This framework will facilitate comparisons across studies and improve generalizability by permitting context-specific interpretation. Research based on this framework should consider the multidisciplinary nature of ICU care and describe the specific program goals. Key topic areas to be addressed include the effect of ICU telemedicine on the structure, process, and outcome of critical care delivery. Ideally, future research should attempt to address causation instead of simply associations and elucidate the mechanism of action in order to determine exactly how ICU telemedicine achieves its effects. ICU telemedicine has significant potential to improve critical care delivery, but high-quality research is needed to best inform its use. We propose an agenda to advance the science of ICU telemedicine and generate research with the greatest potential to improve patient care.

Addition of Dexmedetomidine to Standard Sedation Regimens After Cardiac Surgery: An Outcomes Analysis

Objective:To review the history, training requirements, contributions to patient care outcomes, and workforce issues of critical care pharmacists. Data Source and Selection:Literature obtained through Medline search with manual cross-referencing. Data Extraction and Synthesis:Original and selected review articles and guideline documents were reviewed for references to critical care pharmacists and their role on the multiprofessional critical care team. Conclusions:Critical care pharmacists are recognized as essential members of the critical care team as a result of contributions to medication safety, improved patient outcomes, and reduced drug costs and as a source of drug information and provider of education. A growing number of pharmacists practice in critical care. Additional opportunities exist and can be met if an adequate supply of trained specialists can be developed.