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Critical Care Medicine Section Newsletter - April 2008, Vol 9, #2

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circle_arrowEndocrine Controversies in Critical Care
circle_arrowFrom the Chair - CCM Section Guideline Updates
circle_arrowFrom the Chair Elect - The Transformation of Medical Education-One Minute at a Time
circle_arrowFrom the Councillor - Surviving Sepsis Campaign Updates
circle_arrowFrom the Newsletter Editor - The Pace of Change
circle_arrowReflections on the 37th Critical Care Congress of the Society of Critical Care Medicine

Endocrine Controversies in Critical Care

Critical Care Medicine Section
April 2008, Vol 9, #2

Timothy Ellender, MD
Multidisciplinary CCM Fellow
Methodist Hospital/Clarian Health/Indiana University

Steroids in Sepsis

The debate regarding steroid therapy in sepsis has continued for well over 40 years. The controversies around steroids in sepsis largely evolve around patient selection, duration of therapy, and based on whether the endpoint of therapy is shock reversal or mortality benefit. Annane and coworkers1 showed mortality benefits in the use of low-dose corticosteroids in vasopressor refractory septic shock. Bollaert and others2 showed value of corticosteroids on shock reversal in patients with severe sepsis and septic shock at 7 and 28 days. The timing of corticosteroid administration remains unclear and trials widely vary, ranging from < 8 hours to up to 72 hours.1-3 It is also unclear how best to taper steroids, though most experts agree that a short 5 day course with a rapid taper is optimal.

The CORTICUS trial results, published in January’s New England Journal of Medicine, provided a few additional details, but by no means provided the complete answer to the steroid question.4 CORTICUS researchers analyzed outcomes in 499 patients who were randomized to low-dose steroids (n = 215) or placebo (n = 248). Patients were enrolled if they showed clinical evidence of infection within 72 hours of enrollment, met well-described inclusion criteria for sepsis, and also had a systolic blood pressure <90 mm Hg or the need for vasopressors for at least 1 hour to maintain a systolic blood pressure at 90 mm Hg or greater (shock). The adrenocorticotropic hormone (ACTH) stimulation test was used to identify responders and non-responders, though all patients received either study drug or placebo despite "responsiveness."

Patients randomized to low dose steroids received 50 mg hydrocortisone, given as an IV bolus four times daily for 5 days, then twice daily for the next 3 days, then as a single daily dose between days 9 and 11. The primary end point measured was 28-day all-cause mortality in "nonresponders" (defined as a change of =9 mcg/dL in cortisol after a 250-mcg cortrosyn stimulation test). Secondary end points dealt with mortality in the entire population, organ failure resolution, and safety.

At 28 days, CORTICUS showed no significance in the mortality rates between patients receiving steroids (34.3%) and patients receiving placebo (31.5%). Additionally, responses according to ACTH test results were not statistically different, with mortality rates of 39.2% for nonresponders and 36.1% for responders.

There was a trend toward earlier shock stability in the steroid group, though the study showed no significant difference in the overall degree of reversal of shock between steroid (80%) and placebo patients (74%), nor did early reversal relate to mortality benefit. Secondary effects were also recorded. The incidence of superinfection was higher in the steroid group (33.3%) than in the placebo group (26.3%) and there was more hyperglycemia associated with steroid therapy, yet there was no association between the use of steroids and an increase in polyneuropathy.

Based on the CORTICUS results, the investigators recommended that the ACTH simulation test not be used to identify a subset of adults with septic shock who should receive hydrocortisone therapy. Investigators also suggested that IV hydrocortisone be given only to adult patients after blood pressure is identified to be poorly responsive to fluid resuscitation and vasopressor therapy (refractory hypotension).

It is important to recognize that the CORTICUS trial enrolled a different patient population than the Ananne (French) trial, which demonstrated mortality benefits with early steroids. In contrast to Ananne’s study population, CORTICUS patients were less ill by severity score and it appears that fewer vasopressor refractory patients were allowed entry into the trial which suggests some degree of selection bias. In the CORTICUS trial, patients could be enrolled up to 72 hrs after onset of septic shock as opposed to 8 hrs for the Annane trial. Enrollment in the French trial required persistent hypotension after fluid resuscitation and vasopressor administration, which was not required for the CORTICUS study where patients were simply required to be on vasopressors after fluid resuscitation.

Though CORTICUS was underpowered to provide a definitive answer regarding the role of steroids in septic shock, it did shed light on which patients might best benefit from this controversial therapy. In summary, corticosteroid therapy may be beneficial to some patients with sepsis though they should not be a routine part of a basic early protocol for all patients with severe sepsis/septic shock. The decision to administer steroids in sepsis cannot be based on markers of adrenal function; rather, treatment should be considered in septic patients with vasopressor refractory hypotension (high dose pressors or two pressors).

Glycemic Control in Critical Illness

Hyperglycemia has been correlated with adverse outcomes in critically ill patients with a diverse number of critical etiologies ranging from traumatic brain injury to acute myocardial infarction. Van den Berghe et al5 generated the interest in improved (tight) glycemic control nearly seven years ago. In this trial of over 1500 surgical ICU patients, subjects were randomized either to a more liberal approach tolerating BG levels of up to 200 mg/dL or to an intensive insulin therapy regimen to maintain BG in the 80-110 mg/dL range. In this study, intensive insulin therapy reduced both ICU and hospital mortality. Beneficial secondary effects of tight glycemic control included decreases in blood stream infections, transfusions, and acute renal failure. Researchers did report more severe hypoglycemia with the stricter insulin regimen, but these events did not appear to result in clinical harm. In a 2006 study, Van den Berghe showed similar effects with intensive insulin therapy, which reduced morbidity but not mortality in a medical ICU.6 Van den Berghe’s findings have been criticized as being limited to a single-center and as such, the ability to extrapolate the results to other conditions has been questioned. Despite these early successes, questions remain regarding the optimal targets for blood glucose levels, which patients might benefit from tight glucose control, and the effect of hypoglycemia as an adverse event.

Specifically, concerns have been voiced regarding the safety of tight control and the risks for hypoglycemia. Recent studies, like the GLUCONTROL Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients (GLUCONTROL) have been stopped early due of safety concerns.7 The VISEP trial, a European study of colloids vs crystalloids and intensive insulin therapy reported higher levels of hypoglycemia with nearly 10 times greater prevalence with tighter blood glucose (BG) control. Patients with tight glycemic control had hypoglycemic events that were more closely associated as a life-threatening incident (5.3% vs 2.1%).8 Lastly, the study showed no difference in either 28-day or 90-day mortality based on BG control targets. As with GLUCONTROL, the VISEP study discontinued the insulin portion of the trial after the first safety analysis of 488 patients, because of excess hypoglycemic events with intensive insulin therapy.

Critics have uncovered a number of key flaws in the VISEP study, the most significant of which center around the paired use of hydroxyethyl starch and key faults involving study enrollment. Like others who have reported high levels of hypoglycemia, VISEP researchers used long monitoring intervals for blood glucose surveillance (4 hours) regardless of the use of high dose intravenous insulin. One major potential contributor to the negative VISEP results was the hypoglycemia rate of their protocol (18.7%) which likely masked any potential benefit of intensive insulin therapy. Likewise, centers who have invested in the use of intensive glycemic control have shown remarkably lower glycemic rates (<3%) even with tight control (80-110 mg/dL) with frequent blood glucose measurements (hourly).

In summary, the optimal target range for glycemic control remains to be defined. Centers who invest in glycemic control must evaluate their own clinical resources for glucose monitoring and weigh the risks of hypoglycemia with the potential benefits of improved glucose balance. With the mixed results of recent studies, experts are now suggesting loosening the glycemic control range to 110 to 150 mg per deciliter and are suggesting at least one to two hour blood glucose surveillance intervals to prevent profound hypoglycemic events.

References

  1. Annane D, Sebille V, Charpentier C, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality inpatients with septic shock. JAMA. 2002;288:862-871.
  2. Annane D, Bellissant E, Bollaert P, et al. Corticosteroids for treating severe sepsis and septic shock. Cochrane Database Syst Rev. 2004;(1):CD002243.
  3. Annane D, Bellissant E, Bollaert PE, et al. Corticosteroids for severe sepsis and septic shock: a systematic review and meta-analysis. BMJ. 2004;329(7464):480.
  4. Sprung CL, Annane D, Didier K, et al. Hydrocortisone therapy in patients with septic shock. N Engl J Med. 2008;358;111-124.
  5. Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the critically ill patients. N Engl J Med. 2001;345:1359-1367.
  6. Van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006;354:449-461.
  7. NIH. Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients. Available at: http://www.clinicaltrials.gov/ct/gui/show/NCT00107601 Accessed February 10, 2008.
  8. Brunkhorst FM, Engel C, Bloos F, et al. Intensive insulin therapy and Pentastarch resuscitation in severe sepsis. N Engl J Med. 2008;358:125-139.

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From the Chair - CCM Section Guideline Updates

Critical Care Medicine Section
April 2008, Vol 9, #2

Todd L. Slesinger, MD, FACEP

slesingerOur section continues to make progress in many ways, and I wanted to thank everyone who has participated, especially our officers. We are off to a good start in achieving many of the goals that I described in the previous newsletter. I want to focus this discussion on my first goal, the update of the section operational guidelines to match our current practice.

If any member has comments or concerns, it is imperative that they communicate with us quickly as I will finalize these guidelines by the next newsletter. This is necessary for us to discuss and approve any change at the annual meeting as per existing operational guidelines. A copy of the current guidelines is available through the section website. I will describe the changes without the specific wording details.

We have no planned changes for sections 1-3 and 7-12.

Section 4 deals with the executive committee. We have always had a Newsletter Editor, therefore this position will be held by the same individual, as the duties of the secretary are to distribute the newsletter. I also want to add a 5th position, a Website Editor. Our election cycle has been and will continue to be every two years. This past year we conducted the election on-line prior to the meeting and the process worked well allowing more members to vote. This also, saved time during the meeting. Nominations will be taken from the floor only if there are no nominations for a position in time for the on- line vote."

The only changes in Section 5 are the additions of the Website Editor duties and clarification of the Secretary/Newsletter Editor duties.

Section 6 deals with the Councillor position, with which I am very familiar, having served for more than 5 years. This position is very important in terms of bringing the views of the Section to the annual council meeting. This includes representing the section on any Council resolutions. In past years, we decided that the councillor position should be a seasoned member of the Section, and as is the case with other Sections, be given to the Immediate Past Chair. If the Past Chair cannot serve that function then it would go to the Chair-Elect or Chair. The Alternate Councillor position is a great position for young enthusiastic members and will be an appointed position.

Although these may seem like many changes, they really represent what the section has done for many years, especially when the section was small. These changes will have to be voted on at the next meeting, and they require a two thirds majority vote from those members present to be passed. Then they will be reviewed by the Section Executive Committee and the Board of Directors. These guidelines can always be changed in the future if need be per section 11 of the operational guidelines.

I continue to look forward to a great and productive year for the section and I invite all those interested to contact me with any questions, ideas, and support.

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From the Chair Elect - The Transformation of Medical Education-One Minute at a Time

Critical Care Medicine Section
April 2008, Vol 9, #2

Lillian L. Emlet, MD

emletMedical education has gradually matured, with increased structure, definition, research, and collaboration. From the days of apprenticeship have come academic regulation, 6 core competencies, curriculum definitions, and attempts at individual and program assessment. Through the years, standardization of programs has allowed for more uniform experiences and accountability to the learner and the public. From problem-based learning to evidence-based medicine, simulation to virtual reality, and from cognitive theory to the observed structured clinical exam, medical education has come quite a distance in the last several decades. Despite the incredible amount of new work generated to maintain training programs, the era of defined, scholarly medical education still has potential for growth and refinement.

The accountability of teaching and learning has changed as well. Emphasis has been shifted from simply completing rotations and passing written exams to an evaluation system that ensures the learner becomes a self-directed, self-assessing individual able to cooperatively work well with others and operate within current evidence-directed clinical guidelines. Competency-based education requires ostensible goals and objectives clearly aligned with expected competencies.1 This criteria-driven teaching focuses on achieving benchmarks as a surrogate measurement for competence, individualized to provide more independent development and focused on fostering one’s ability to self-assess. Gradually, over time, the graduate medical accreditation process has become more focused on setting, achieving, and measuring such standards. Determining performance standards is a challenge for medical education, especially since evidence-based gold standards and well validated methods for measurements are not available. In essence, these performance measures aim to assign value to performance in real-life experiences, the medical Holy Grail by which most of our educational interventions should be measured.

The daily struggle we all face as clinicians and educators is to balance the care of the patient with the care of the learner.2 Finding the right time to do so in the emergency department and the ICU can be challenging, but not impossible. Balancing the immediate needs of resuscitation with the needs of a novice medical trainee sometimes feels quite difficult, but I suggest that these most exciting times are when learning is at its best. Whether it be while observing physiologic changes in a critically ill patient, while performing multiple invasive procedures in the ICU, or through participation in a cardiac arrest in the emergency department, opportunities to encourage, nudge, refine, and model good clinical practices are abundant. It is during these moments that the less confident can practice their ability to run a code, place the first of many central lines, or struggle through delivering bad news to family members. It is in these moments that we sometimes forget to find the teachable moment, but it is in these moments that our role modeling, feedback, and reflection is most important.

Our goal when supervising students and residents is to identify the meaningful educational objective in that moment and tailor it to the individual learner. As the trainee progresses from reporter of information to manager of clinical care, different skills may need to be refined. A strategy to refine the learner includes careful reflective questions that ask the learner to justify examination, diagnosis, or treatment. A possible quick solution is the one-minute preceptor model, or the five-step micro-skills model.3-5 The basic steps of this model are as follows:

  1. Get a commitment from the learner—"What do you think is going on?"
  2. Probe for supporting reasoning—"What clinical findings led you to that?"
  3. Teach general rules—"Use an end-expiratory pause to find out how much auto-peep the patient has on this volume-cycled mode of ventilation."
  4. Give positive feedback—"Your summary of the ICU course thus far was excellent."
  5. Correct errors—"When you see ventilator dyssynchrony occurring, it is important to try maneuvers to correct it as soon as possible."

The advantages of this method is that it allows both novice and expert learners the opportunity to describe their thought processes, identify knowledge gaps together as a team, and explore evidence-based areas for each learner to look into. For example, for the medical student, this may reveal a need to describe basic physiology, pharmacology, and microbiology as it relates to the patient in septic shock. For the resident, the ability to recognize clinical signs of respiratory failure and ensure smooth steps for intubation might apply. For the fellow, synthesizing multiple organ failure in terms that allow them to educate and prognosticate to families and lead a team of residents would be pertinent. Lastly, providing feedback consistently is important to ensure that good traits are encouraged and less desirable habits fade away. It is important to debrief and talk about performance even in the busiest and emotionally charged situations, such as cardiac arrest resuscitations.

In conclusion, while the amount of time that clinician-educators spend documenting for training program compliance does sometimes feel excessive, the real daily diagnosis and care of the learner occurs at the bedside. By serving to continually challenge each other and work as team to learn and improve each patient’s care, we are able to also impact the care of the learner. Guided by new standards and reflective actions, we transform medical education one minute at a time.

References

  1. ACGME. Outcomes Project. http://www.acgme.org/Outcome/ Last accessed February 18, 2008.
  2. Bowen JL. Educational strategies to promote clinical diagnostic reasoning. N Engl J Med. 2006; 355:2217-2225.
  3. Aagaard E, Teherani A, Irby DM. Effectiveness of the one-minute preceptor model for diagnosing the patient and the learner: proof of concept. Acad Med. 2004; 79:42-49.
  4. Teherani A, O’Sullivan P, Aagaard EM, et al. Student perceptions of the one minute preceptor and traditional preceptor models. Med Teach. 2007; 29:323-327.
  5. Parrott S, Dobbie A, Chumley H, et al. Evidence-based office teaching-the five-step microskills model of clinical teaching. Fam Med. 2006; 38:164-167.

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From the Councillor - Surviving Sepsis Campaign Updates

Critical Care Medicine Section
April 2008, Vol 9, #2

Tiffany M. Osborn, MD, FACEP

osborneThe 2008 Surviving Sepsis Campaign international guidelines for the treatment of severe sepsis and septic shock is an update that builds upon the first 2 editions. The 2001 guidelines were based upon the preceding 10 years of data. The 2004 edition incorporated new information through the end of 2003 and the 2008 guidelines contain information through 2007. The 2001 guidelines were coordinated by the International Sepsis Forum, the 2004 guidelines were supported by unrestricted educational grants from industry, and the 2008 guidelines were coordinated by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine with no industry funding supporting guideline committee activities.

In the recent guideline update there were a few important revisions. The first was methodology. The SSC enlisted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) group to provide the most advanced information on guideline development possible for the 2008 SSC revisions. GRADE experts were present at the guideline committee meetings to assist with facilitating consistent methodological data review and processing. Additionally, representatives from GRADE were present during e-mail deliberations and available for additional questions. Specific details are available in the SSC guideline article.

The resuscitation guidelines remain unchanged except for the addition of further supportive evidence of mortality benefit for early goal directed therapy. The most relevant clinical updates for emergency medicine were in antibiotics, steroids and vasopressin.

Antibiotics are recommended as soon as possible and within the first hour for septic shock (1B) and severe sepsis without shock (1D). This was based on data that showed if appropriate antibiotics were administered within the first hour of hypotension in septic patients, survival was an estimated 75%. Every hour delay after that point through the ensuing 6 hours resulted in a 7.6% increase in mortality [1].

Steroids are suggested in hypotensive patients’ refractory to fluid and vasopressor management (2C). An excellent review is given on the data surrounding steroids in this newsletter – please see page.

Vasopressin levels may be inappropriately decreased in septic shock patients. Known as relative vasopressin deficiency, it has been treated with physiologic vasopressin. The VASST trial found no difference between vasopressin + norepinephrine and norepinephrine alone in the intention to treat population. However, two a priori-defined subgroups were included in the power analysis for the study and demonstrated mortality benefit in the group being treated with <15 Mcg/min of norepinephrine + vasopressin but not effective once norepinephrine was above 15Mcg/min.

The SSC guidelines article, the pocket version, and tools for starting a sepsis program are accessible for free via the website (www.acep.org/sepsis ).

Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006; 34(6):1589-1596.

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From the Newsletter Editor - The Pace of Change

Critical Care Medicine Section
April 2008, Vol 9, #2

Timothy Ellender, MD

ellenderI am again humbled and grateful to be allowed to comment amongst the authors of this Section Newsletter. This letter covers a full spectrum of issues ranging from the reporting of the Section’s efforts to remain updated within the ACEP Guidelines to our participation with ACEP’s counterpart section within the Society of Critical Care Medicine (SCCM). In this newsletter, Lillian pens a provocative piece on education and reflects on the drastic changes underway in graduate medical education and the shifting focus on the "care of the learner." Additionally, we present several updates on controversial topics in critical care and supply several concise updates on sepsis care paradigms that impact the emergency medical and critical care practitioner.

The maturation of EM-CCM education continues. There has been a growing dialogue regarding improving our own educational structure and the collaborative exchange to support grass roots educational efforts has increased. At least two new EM-CCM fellowships are slated to begin training new fellows within the next year and other existing programs (anesthesia, internal medicine, and surgery) have expanded their intake processes to include emergency trained residents. Our fellow graduates continue to fill competitive jobs many of which are located within acclaimed academic institutions which were once conflicted by the EM-CCM debate while others have found pioneering positions in underserved markets gasping for critical care leadership.

Beyond the activities of our own Section, other organizations that support critical care education have continued to advance their educational offerings. There are a host of online provisions, high quality reviews, and centralized lectures offered through the American College of Chest Physicians, the American Thoracic Society, and the Society of Critical Care Medicine. Additionally, the European CoBaTrICE consortium continues to add and update resources that are available on their site (www.cobatrice.org ).

Here is a sample of the resources that are available via the web:

American Thoracic Society Critical Care Education Section
http://www.thoracic.org/clinical/critical-care/index.php

American College of Chest Physician’s Education Section
http://www.chestnet.org/education/index.php

European Society of Intensive Care Medicine’s Education Section
http://www.esicm.org/Data/ModuleGestionDeContenu/PagesGenerees/03-education/24.asp

Society of Critical Care Medicine’s Education Section
http://www.learnicu.org/Pages/default.aspx

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Reflections on the 37th Critical Care Congress of the Society of Critical Care Medicine

Critical Care Medicine Section
April 2008, Vol 9, #2

J. Christopher Skinner, MD
Multidisciplinary CCM Fellow
Methodist Hospital/Clarian Health/Indiana University

skinnerThe 37th Critical Care Congress of the Society of Critical Care Medicine in Honolulu was not only fun and educational, but was also clinically reassuring. As a first- year fellow in a newly formed EM-CCM fellowship, this was my inaugural attendance at this national meeting. I will not gloat about the setting. I will just say that there are worse places to be in February than Hawaii.

Educationally, there was a broad range of topics covered in the program that ran the gamut of critical care delivery. It was often difficult to choose which session to attend when so many interesting subjects were being covered simultaneously. Some of the sessions that I attended discussed controversies in red blood cell transfusions, goals and markers of resuscitation effectiveness in sepsis, and strategies to reduce mortality in sepsis. Other sessions reviewed management of deep venous thrombosis and pulmonary embolism, controversies in monitoring and treating neuro-trauma, assessment of tissue perfusion, updates in ARDS, approaches to delirium and pain management in the ICU, and the benefits of sex hormones in critically ill patients. Needless to say the meeting was thought provoking, stimulated my desire to continue training, and continue my drive to further my knowledge base and aid my care of the critically ill.

I left this meeting encouraged and reassured that I had chosen the right career path and training center. Training in a large tertiary referral center that is staffed by community physicians, I often wonder if our practice patterns mimic the national trends. I had fears that not being in a purely academic model or in a program that had yet to produce a graduate would possibly present some gaps in the training of a critical care physician. The SCCM meeting allayed those doubts by reviewing an abundance of critical care topics and recent research that currently coincide with the practice model and training theories of my own institution. Furthermore, the clinical scenarios that give me pause and seem particularly challenging on a day to day basis appear to be challenging for most critical care practitioners who attended the SCCM meeting.

It was also affirming that the lists of nationally recognized speakers at many of the sessions featured physicians primarily trained in emergency medicine. As a physician who has just begun a critical care career track that is often referred to as "non-traditional," it was particularly motivating to see the critical care community asking EM-CCM trained physicians to present their expert opinion at this national meeting. It is also encouraging to see that our presence is not only being accepted, but that our input is being expected.

Finally, the SCCM EM section meeting was well attended and represented many EM-CCM physicians who are scattered throughout the country. This meeting not only offered attendees an opportunity to network, it also summarized a host of activities impacting the national face of EM-CCM. Dr. Julie Mayglothling presented a poster demonstrating the ever growing number of physicians who are board certified or eligible in emergency medicine. This growth has correlated with the growing number of emergency physicians that have completed critical fellowships. The section meeting further proved encouraging as evidenced by the role call of attendees who held diverse positions within the health care structure. These positions ranged from attending physicians in emergency departments and critical care units to fellowship, research, and ICU directorships.

I thought the experience provided a well rounded view of the politics, science, and zeal that is critical care. I encourage other residents and fellows to attend the SCCM Congress at some time during their training as it offers a host of benefits that extend beyond the obvious educational objectives.

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