Therapeutic hypothermia after out-of-hospital cardiac arrest in children.

BACKGROUND: Therapeutic hypothermia is recommended for comatose adults after witnessed out-of-hospital cardiac arrest, but data about this intervention in children are limited. METHODS: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. RESULTS: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P=0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P=0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P=0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. CONCLUSIONS: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.).

Comparison of methods for the detection of medication safety events in the critically ill.

PURPOSE: To categorize and synthesize medication safety event detection methods in the critically ill in order to provide clinicians and administrators with approaches to event detection that are intended to expand and complement traditional voluntary reporting systems. METHODS: A literature search of OvidMEDLINE was performed to identify articles related to medication safety involving critically ill patients in the intensive care unit setting. The inclusion of articles was restricted to comparative studies. The bibliographies of all retrieved articles were reviewed to obtain additional articles of relevance. The various event detection methods were compared by: evidence supporting their use; number, type and severity of events detected; phase of the medication use process in which events were detected; and ease and cost of implementation. Major limitations of each method were also collated. RESULTS: There are a number of methods that can be used to identify medication safety events in the critically ill. These can broadly be categorized as: 1) voluntary reporting, 2) record review, 3) rules/triggers and 4) direct observation and 5) interviews/surveys. Relatively few studies have directly compared these assessment methods in the ICU setting, although the limitations of the traditional voluntary reporting system as the sole method of event detection are well established. Although not truly dichotomous, these methods can be broken down into more proactive and reactive approaches. Rules/triggers and direct observation of the medication use process in the ICU are examples of proactive approaches to event detection, while the traditional unsolicited voluntary reporting is typically reactive. However, each of the event detection methods has advantages and disadvantages, so the methods should not be considered mutually exclusive with respect to obtaining information about medication safety. CONCLUSIONS: Given the limitations of traditional voluntary reporting systems, a multimodal approach used to identify medication safety events is most likely to capture the largest number and type of events. We would advise not trying to implement additional approaches beyond voluntary reporting systems all at once. This would be difficult and costly. Rather, we suggest a systematic implementation of additional event detection approaches that takes into account hospital-specific considerations.

Interdisciplinary patient care in the intensive care unit: focus on the pharmacist.

The field of critical care medicine began to flourish only within the last 40 years, yet it provides some of the best examples of collaborative pharmacy practice models and evidence for the value of pharmacist involvement in interdisciplinary practice. This collaborative approach is fostered by critical care organizations that have elected pharmacists into leadership positions and recognized pharmacists through various honors. There is substantial literature to support the value of the critical care pharmacist as a member of an interdisciplinary intensive care unit (ICU) team, particularly in terms of patient safety. Furthermore, a number of economic investigations have demonstrated cost savings or cost avoidance with pharmacist involvement. As the published evidence supporting pharmacist involvement in patient care activities in the ICU setting has increased, surveys have demonstrated an increase in the percentage of pharmacists performing clinical activities. In addition, substantial support of pharmacists has been provided by other clinicians, safety officers, and administrative personnel who have been involved with the initiation and expansion of critical care pharmacy services in their own institutions. Although there is still room for improvement in the range of pharmacist involvement, particularly with respect to interdisciplinary activities related to education and scholarship, pharmacists have become essential members of interdisciplinary care teams in ICU settings.

Antivenom for critically ill children with neurotoxicity from scorpion stings.

BACKGROUND: Clinically significant scorpion envenomation by Centruroides sculpturatus produces a dramatic neuromotor syndrome and respiratory insufficiency that often necessitate intensive supportive care. We hypothesized that a scorpion-specific F(ab')(2) antivenom would promptly resolve clinical symptoms in children with this syndrome. METHODS: In a randomized, double-blind study, the efficacy of scorpion-specific F(ab')(2) antivenom, as compared with placebo, was assessed in 15 children 6 months to 18 years of age who were admitted to a pediatric intensive care unit with clinically significant signs of scorpion envenomation. The primary end point was the resolution of the clinical syndrome within 4 hours after administration of the study drug. Secondary end points included the total dose of concomitant midazolam for sedation and quantitative plasma venom levels, before and after treatment. RESULTS: The clinical syndrome resolved more rapidly among recipients of the antivenom than among recipients of placebo, with a resolution of symptoms in all eight antivenom recipients versus one of seven placebo recipients within 4 hours after treatment (P=0.001). More midazolam was administered in the placebo recipients than in the antivenom recipients (mean cumulative dose, 4.61 vs. 0.07 mg per kilogram of body weight; P=0.01). Plasma venom concentrations were undetectable in all eight antivenom recipients but in only one placebo recipient 1 hour after treatment (P=0.001). CONCLUSIONS: Among critically ill children with neurotoxic effects of scorpion envenomation, intravenous administration of scorpion-specific F(ab')(2) antivenom resolved the clinical syndrome within 4 hours, reduced the need for concomitant sedation with midazolam, and reduced the levels of circulating unbound venom. (ClinicalTrials.gov number, NCT00685230.)

Serum levels and urine detection of Centruroides sculpturatus venom in significantly envenomated patients.

INTRODUCTION: Envenomation by Centruroides sculpturatus can cause systemic signs and symptoms requiring treatment. The toxicokinetics of C. sculpturatus venom has not been described. METHODS: Venom components were separated for cross-reactivity testing. Serum and urine collected from three patients envenomated by C. sculpturatus had venom levels determined by sandwich enzyme-linked immunosorbent assay (ELISA). RESULTS: Western blot analysis indicated recognition of C. sculpturatus venom by Alacramyn, an equine F(ab')(2) antivenom developed against Centruroides scorpion venoms, including C. sculpturatus. Serum venom levels in ng/mL with post-envenomation times in minutes (min) were as follows: 85-year-old woman = 8.2 (approximately 150), 2.8 (515), 1.6 (1,200); 14-month-old girl = 29.7 (approximately 50), 5.0 (729); 3-year-old girl = 11.1 (approximately 313), urine venom level of 9.0 (approximately 490). CONCLUSION: There is sufficient venom cross-antigenicity among different Centruroides species to allow this ELISA technique with Alacramyn to determine serum and urine C. sculpturatus venom concentrations in envenomated patients.

Direct observation approach for detecting medication errors and adverse drug events in a pediatric intensive care unit.

OBJECTIVE: To determine the incidence, type, and stage of occurrence of medication errors and potential and actual adverse drug events (ADEs) in a pediatric intensive care unit (ICU) using trained observers. The preventability and severity of ADEs and the system failures leading to medication error occurrence were also investigated. DESIGN: Prospective, direct observation study. SETTING: A 16-bed pediatric medical/surgical ICU at a tertiary care academic medical center. PATIENTS: One enrolled nurse caring for at least one pediatric ICU patient age <18 yrs was randomly chosen during each observation period. INTERVENTIONS: Observers would intervene only in the event that the medication error would cause substantial patient harm or discomfort. MEASUREMENTS AND MAIN RESULTS: Medication errors and potential and actual ADEs were identified throughout the entire medication use process. The 26 12-hr observation periods included 357 reviewed written orders and 263 observed doses. The study observers identified 58 incidents, which were subsequently classified by the evaluators according to clinical importance, severity, and preventability. Fifty-two of these incidents were considered medication errors; six incidents were determined to be nonpreventable ADEs. Of the 52 medication errors, 42 (81%) were considered clinically important. Potential ADEs comprised 35 (83%) of these important medication errors; the other seven (17%) were classified as actual, preventable ADEs. Overall, the actual and potential ADE rate occurred at 3.6 events and 9.8 events per 100 orders, respectively. CONCLUSIONS: Our medication error rate was similar to that of previous pediatric ICU studies that used the direct observation method for reporting but higher than the rates in previous studies using other detection techniques such as voluntary incident reporting. Periodic direct observation and other ongoing data collection methods such as voluntary incident reporting have the potential to be complementary approaches to medication error and ADE detection.

Medication errors and adverse drug events in an intensive care unit: direct observation approach for detection.

OBJECTIVE: To determine the incidence and preventability of medication errors and potential/actual adverse drug events. To evaluate system failures leading to error occurrence. DESIGN: Prospective, direct observation study. SETTING: Tertiary care academic medical center. PATIENTS: Patients in a medical/surgical intensive care unit. INTERVENTIONS: Observers would intervene only in the event that the medication error would cause substantial patient harm or discomfort. MEASUREMENTS AND MAIN RESULTS: The observers identified 185 incidents during a pilot period and four phases totaling 16.5 days (33 12-hr shifts). Two independent evaluators concluded that 13 of 35 (37%) actual adverse drug events were nonpreventable (i.e., not medication errors). An additional 40 of the remaining 172 medication errors were judged not to be clinically important. Of the 132 medication errors classified as clinically important, 110 (83%) led to potential adverse drug events and 22 (17%) led to actual, preventable adverse drug events. There was one error (i.e., resulting in a potential or actual, preventable adverse drug event) for every five doses of medication administered. The potential adverse drug events mostly occurred in the administration and dispensing stages of the medication use process (34% in each); all of the actual, preventable adverse drug events occurred in the prescribing (77%) and administration (23%) stages. Errors of omission accounted for the majority of potential and actual, preventable adverse drug events (23%), followed by errors due to wrong dose (20%), wrong drug (16%), wrong administration technique (15%), and drug-drug interaction (10%). CONCLUSIONS: Using a direct observation approach, we found a higher incidence of potential and actual, preventable adverse drug events and an increased ratio of potential to actual, preventable adverse drug events compared with studies that used chart reviews and solicited incident reporting. All of the potential adverse drug events and approximately two thirds of the actual adverse drug events were judged to be preventable. There was one preventable error for every five doses of medication administered; most errors were due to dose omission, wrong dose, wrong drug, wrong technique, or interactions.

Femoral central venous catheter-associated deep venous thrombosis in children with diabetic ketoacidosis.

OBJECTIVE: To describe the incidence of clinical deep venous thrombosis associated with femoral central venous catheters (CVC-DVT) in children with diabetic ketoacidosis (DKA). DESIGN: Retrospective case-matched control series. SETTING: Pediatric intensive care units of two university-affiliated hospitals. PATIENTS: All eight pediatric DKA patients with femoral central venous catheters between 1998 and 2001, and 16 age-matched control patients with femoral central venous catheters and circulatory shock. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The records of all children with DKA and the control patients were reviewed. CVC-DVT was defined as persistent ipsilateral leg swelling after removal of a femoral central venous catheter. Control patients with coagulopathies, thrombocytopenia, cancer, and hyperglycemia were excluded. Four of eight patients with DKA developed CVC-DVT compared with none of the 16 control patients (p = .007, Fisher's exact test). All four patients with DKA and CVC-DVT were <3 yrs old. Doppler ultrasound examination was performed on three of the four patients with clinical CVC-DVT, confirming the diagnosis in each case. CONCLUSIONS: This study suggests that young children with DKA have an increased incidence of clinical DVT associated with the placement of femoral central venous catheters.