[Show abstract][Hide abstract] ABSTRACT: Background: Although its mechanisms are poorly understood, desensitization has been used to induce a temporary state of immune unresponsiveness in patients who have IgE-, non-IgE-, or pharmacologically mediated reactions when a drug has no alternatives. Objectives: The purpose of this study was to characterize the outcomes and identify risk factors for reactions during drug desensitization. Methods: A retrospective review of electronic medical records of adult patients undergoing drug desensitization from January 1, 2011, to December 31, 2013, was conducted in 2 intensive care units at a tertiary medical center. We used multivariate analysis to determine if specified risk factors were associated with reacting during the desensitization. Reactions were classified according to the pretest probability prior to desensitization, and then, reactions during desensitization were classified based on the occurrence of cutaneous reactions as follows: successful with no reaction, mild reaction, moderate reaction, or failed. Failure could result from any systemic allergic or cutaneous reaction resulting in procedure termination. The desensitizations were also assessed to determine if the patient required de-escalation secondary to a reaction. Results: A total of 88 desensitizations were performed in 69 patients. Desensitization was completed with no cutaneous reaction in 85% of patients. No baseline characteristic, medication class (P = 0.46), or indication for desensitization (P = 0.59) was associated with having a reaction. Reported histories of urticaria (P < 0.0001) and labored breathing (P = 0.003) during prior exposure were significant in identifying patients who might have a reaction during desensitization. However, neither history of urticaria nor labored breathing was independently associated with having a reaction in multivariate analysis (OR = 0.979, 95% CI = 0.325-2.952, P = 0.970, and OR = 1.626, 95% CI = 0.536-4.931, P = 0.739, respectively). Conclusions: Drug desensitization is safe for patients who have no alternative for therapy. Reported allergy histories of urticaria and labored breathing are both associated with having a reaction during the desensitization process.
No preview · Article · Jan 2016 · Annals of Pharmacotherapy
[Show abstract][Hide abstract] ABSTRACT: Objectives:
In acute respiratory distress syndrome, conservative fluid management increases ventilator-free days without affecting mortality. Response to fluid management may differ based on patients' initial central venous pressure. We hypothesized that initial central venous pressure would modify the effect of fluid management on outcomes.
Retrospective analysis of the Fluid and Catheter Treatment Trial, a multicenter randomized trial comparing conservative with liberal fluid management in acute respiratory distress syndrome. We examined the relationship between initial central venous pressure, fluid strategy, and 60-day mortality in univariate and multivariable analysis.
Twenty acute care hospitals.
Nine hundred thirty-four ventilated acute respiratory distress syndrome patients with a central venous pressure available at enrollment, 609 without baseline shock (for whom fluid balance was managed by the study protocol).
Measurements and main results:
Among patients without baseline shock, those with initial central venous pressure greater than 8 mm Hg experienced similar mortality with conservative and liberal fluid management (18% vs 18%; p = 0.928), whereas those with central venous pressure of 8 mm Hg or less experienced lower mortality with a conservative strategy (17% vs 36%; p = 0.005). Multivariable analysis demonstrated an interaction between initial central venous pressure and the effect of fluid strategy on mortality (p = 0.031). At higher initial central venous pressures, the difference in treatment between arms was predominantly furosemide administration, which was not associated with mortality (p = 0.122). At lower initial central venous pressures, the difference between arms was predominantly fluid administration, with additional fluid associated with increased mortality (p = 0.013).
Conservative fluid management decreases mortality for acute respiratory distress syndrome patients with a low initial central venous pressure. In this population, the administration of IV fluids seems to increase mortality.
No preview · Article · Jan 2016 · Critical care medicine
[Show abstract][Hide abstract] ABSTRACT: Background:
Acute Care Nurse Practitioners (ACNPs) are increasingly being employed in intensive care units (ICU) to offset physician shortages, but no data exist about outcomes of critically ill patients continuously cared for by ACNPs.
Prospective cohort study of all admissions to an adult medical ICU in an academic, tertiary-care center between January 1, 2011 and December 31, 2013. The primary endpoint of 90-day survival was compared between patients cared for by ACNP and resident teams using Cox-proportional hazards regression. Secondary end points included ICU and hospital mortality and ICU and hospital length of stay.
Among 9,066 admissions there was no difference in 90-day survival for patients cared for by ACNP or resident teams [adjusted hazard ratio (HR) 0.94; 95% CI, 0.85 to 1.04 P=0.21]. Although patients cared for by ACNPs had lower ICU mortality (6.3%) than resident team patients (11.6%), [adjusted OR 0.77; 95% CI 0.63 to 0.94 P=0.01], hospital mortality was not different (10.0% versus 15.9%) [adjusted OR 0.87 95% CI 0.73 to 1.03 P=0.11]. ICU length of stay was similar between the ACNP and resident teams (3.4±3.5 days versus 3.7±3.9 days, [adjusted OR 1.01; 95% CI 0.93 to 1.1 P=0.81] but hospital length of stay was shorter for patients cared for by ACNPs (7.9±11.2 days) than for resident patients (9.1±11.2 days), [adjusted OR 0.87 95% CI 0.80 to 0.95, P=0.001].
Outcomes are comparable for critically ill patients cared for by ACNP and resident teams.
[Show abstract][Hide abstract] ABSTRACT: Recent emphasis has been placed on methods to predict fluid-responsiveness (FR), but the utility of using fluid boluses to increase cardiac index (CI) in critically-ill patients with ineffective circulation or oliguria remains unclear.
Retrospective analysis investigating hemodynamic responses of critically ill patients in the ARDS Network Fluid and Catheter Treatment Trial (FACTT) who were given protocol-based fluid boluses. FR was defined as ≥15% increase in CI after a 15ml/kg fluid bolus.
A convenience sample of 127 critically-ill patients enrolled in FACTT was analyzed for physiologic responses to 569 protocolized crystalloid or albumin boluses given for shock, low urine output (UOP), or low pulmonary artery occlusion pressure (PAOP). There were significant increases in mean central venous pressure (9.9±4.5 to 11.1±4.8 mmHg, p<0.0001) and mean PAOP (11.6±3.6 to 13.3±4.3 mmHg, p<0.0001) following fluid boluses. However, there were no significant change in UOP, and clinically small changes in heart rate (HR), mean arterial pressure (MAP), and CI. Only 23% of fluid boluses led to a ≥15% change in CI. There was no significant difference in the frequency of fluid responsiveness between boluses given for shock or oliguria versus boluses given only for low PAOP (24.0% vs. 21.8%, p=0.59). There were no significant differences in 90-day survival, need for hemodialysis, or return to unassisted breathing between patients defined as fluid responders and fluid non-responders.
In this cohort of critically-ill and previously resuscitated ARDS patients, the rate of fluid responsiveness was low and fluid boluses only led to small hemodynamic changes.
[Show abstract][Hide abstract] ABSTRACT: To determine whether addition of an electronic sepsis evaluation and management tool to electronic sepsis alerting improves compliance with treatment guidelines and clinical outcomes in septic ICU patients.
A pragmatic randomized trial.
Medical and surgical ICUs of an academic, tertiary care medical center.
Four hundred and seven patients admitted during a 4-month period to the medical or surgical ICU with a diagnosis of sepsis established at the time of admission or in response to an electronic sepsis alert.
Patients were randomized to usual care or the availability of an electronic tool capable of importing, synthesizing, and displaying sepsis-related data from the medical record, using logic rules to offer individualized evaluations of sepsis severity and response to therapy, informing users about evidence-based guidelines, and facilitating rapid order entry.
There was no difference between the electronic tool (218 patients) and usual care (189 patients) with regard to the primary outcome of time to completion of all indicated Surviving Sepsis Campaign 6-hour Sepsis Resuscitation Bundle elements (hazard ratio, 1.98; 95% CI, 0.75-5.20; p = 0.159) or time to completion of each element individually. ICU mortality, ICU-free days, and ventilator-free days did not differ between intervention and control. Providers used the tool to enter orders in only 28% of available cases.
A comprehensive electronic sepsis evaluation and management tool is feasible and safe but did not influence guideline compliance or clinical outcomes, perhaps due to low utilization.
No preview · Article · Apr 2015 · Critical care medicine
[Show abstract][Hide abstract] ABSTRACT: Rationale Effective teamwork is fundamental to the management of medical emergencies and yet the best method to teach teamwork skills to trainees remains unknown. Objectives In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively-assessed teamwork behavior superior to traditional didactics. Methods This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Team Behavior Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel "Recognize, Respond, Reassess" (3R) score. Measurements and Main Results Participants randomized to didactics (n=18), demonstration (n=17), and simulation (n=17) were similar at baseline. The primary outcome of average overall Team Behavior Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, p=0.917) and significantly higher than didactic instruction (4.40 ± 1.15 versus 3.10 ± 0.51, p=0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (Rs2=0.267, p < 0.001). Conclusions Among incoming internal medicine interns, teamwork training by expert demonstration resulted in similar teamwork behavior to participation in high-fidelity simulation and was more effective than traditional didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities.
[Show abstract][Hide abstract] ABSTRACT: Daily bathing of critically ill patients with the broad-spectrum, topical antimicrobial agent chlorhexidine is widely performed and may reduce health care-associated infections.
To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of health care-associated infections.
A pragmatic cluster randomized, crossover study of 9340 patients admitted to 5 adult intensive care units of a tertiary medical center in Nashville, Tennessee, from July 2012 through July 2013.
Units performed once-daily bathing of all patients with disposable cloths impregnated with 2% chlorhexidine or nonantimicrobial cloths as a control. Bathing treatments were performed for a 10-week period followed by a 2-week washout period during which patients were bathed with nonantimicrobial disposable cloths, before crossover to the alternate bathing treatment for 10 weeks. Each unit crossed over between bathing assignments 3 times during the study.
The primary prespecified outcome was a composite of central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), ventilator-associated pneumonia (VAP), and Clostridium difficile infections. Secondary outcomes included rates of clinical cultures that tested positive for multidrug-resistant organisms, blood culture contamination, health care-associated bloodstream infections, and rates of the primary outcome by ICU.
During the chlorhexidine bathing period, 55 infections occurred: 4 CLABSI, 21 CAUTI, 17 VAP, and 13 C difficile. During the control bathing period, 60 infections occurred: 4 CLABSI, 32 CAUTI, 8 VAP, and 16 C difficile. The primary outcome rate was 2.86 per 1000 patient-days during the chlorhexidine and 2.90 per 1000 patient-days during the control bathing periods (rate difference, -0.04; 95% CI, -1.10 to 1.01; P = .95). After adjusting for baseline variables, no difference between groups in the rate of the primary outcome was detected. Chlorhexidine bathing did not change rates of infection-related secondary outcomes including hospital-acquired bloodstream infections, blood culture contamination, or clinical cultures yielding multidrug-resistant organisms. In a prespecified subgroup analysis, no difference in the primary outcome was detected in any individual intensive care unit.
In this pragmatic trial, daily bathing with chlorhexidine did not reduce the incidence of health care-associated infections including CLABSIs, CAUTIs, VAP, or C difficile. These findings do not support daily bathing of critically ill patients with chlorhexidine.
clinicaltrials.gov Identifier: NCT02033187.
No preview · Article · Jan 2015 · JAMA The Journal of the American Medical Association
[Show abstract][Hide abstract] ABSTRACT: Background Vanderbilt University Hospital's original rapid response team included a critical care charge nurse and a respiratory therapist. A frequently identified barrier to care was the time delay between arrival of the rapid response team and arrival of the primary health care team. Objective To assess the impact of adding an acute care nurse practitioner to the rapid response team. Methods Acute care nurse practitioners were added to surgical and medical rapid response teams in January 2011 to diagnose and order treatments on rapid response calls. Results In 2011, the new teams responded to 898 calls, averaging 31.8 minutes per call. The most frequent diagnoses were respiratory distress (18%), postoperative pain (13%), hypotension (12%), and tachyarrhythmia (10%). The teams facilitated 360 transfers to intensive care and provided 3056 diagnostic and therapeutic interventions. Communication with the primary team was documented on 97% of the calls. Opportunities for process improvement were identified on 18% of the calls. After implementation, charge nurses were surveyed, with 96% expressing high satisfaction associated with enhanced service and quality. Conclusions Teams led by nurse practitioners provide diagnostic expertise and treatment, facilitation of transfers, team communication, and education.
No preview · Article · Feb 2014 · Critical Care Nurse
[Show abstract][Hide abstract] ABSTRACT: Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible.
Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected.
Thirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV.
Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring.
[Show abstract][Hide abstract] ABSTRACT: Introduction: Sepsis is common in both medical and surgical ICU patients and a better understanding of population-based course of sepsis coupled with the use of early protocolized care facilitated by an Integrated Electronic Management Tool, may lead to improved outcomes Methods: In this randomized trial, a sepsis tool, available via the EMR throughout the ICU stay in both medical and surgical ICUs, presented a divided display with one half graphing trend and goal for HR, MAP, CVP, Hgb, and lactate and the other half offering sepsis assessment and management tabs in a work-flow modeled on the Surviving Sepsis Campaign 2008 guidelines with one-click order entry for labs, cultures, imaging, antibiotics, and goal-directed resuscitation Results: Of 280 medical and 66 surgical patients with suspected sepsis, 164 (medical 133, surgical 31) were randomized to control vs 182 (medical 147, surgical 35) to the electronic sepsis management tool, The utilization of the management tool to enter orders based on best practice guidelines for the management of sepsis was 9.3% in the MICU vs. 27.3% in the SICU (p<0.001). 18% of the MICU patients came from an OSH and 71.2% of the SICU patients were post-operative with a higher acknowledgement of sepsis at admission. Source of sepsis was pulmonary in 29.6% of MICU patients vs. 11.5% of SICU patients, while an abdominal source of sepsis occurred in 54.1% of SICU patients and only 13% of MICU patients. ICU mortality in septic MICU patients was 16.5% vs. 4.5% in SICU Conclusions: This study highlights the population-based differences in medical and surgical sepsis with septic medical patients having significantly more pulmonary source of infection versus abdominal source for surgical patients. Surgical ICU patients had a higher acknowledgement of sepsis on admission to the ICU and increased utilization of the management tool to place outstanding orders, not already fulfilled in the Operative Room. The low overall utilization of the integrated electronic management tool in both units likely decreases its overall effectiveness.