METHODS: In this post hoc analysis of the EFFORT Protein trial, we investigated the effect of high versus usual protein dose (≥ 2.2 vs. ≤ 1.2 g/kg body weight/day) on time-to-discharge alive from the hospital (TTDA) and 60-day mortality and in different subgroups in critically ill patients with AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria within 7 days of ICU admission. The associations of protein dose with incidence and duration of kidney replacement therapy (KRT) were also investigated.
RESULTS: Of the 1329 randomized patients, 312 developed AKI and were included in this analysis (163 in the high and 149 in the usual protein dose group). High protein was associated with a slower time-to-discharge alive from the hospital (TTDA) (hazard ratio 0.5, 95% CI 0.4-0.8) and higher 60-day mortality (relative risk 1.4 (95% CI 1.1-1.8). Effect modification was not statistically significant for any subgroup, and no subgroups suggested a beneficial effect of higher protein, although the harmful effect of higher protein target appeared to disappear in patients who received kidney replacement therapy (KRT). Protein dose was not significantly associated with the incidence of AKI and KRT or duration of KRT.
CONCLUSIONS: In critically ill patients with AKI, high protein may be associated with worse outcomes in all AKI stages. Recommendation of higher protein dosing in AKI patients should be carefully re-evaluated to avoid potential harmful effects especially in patients who were not treated with KRT.
TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT03160547) on May 17th 2017.
OBJECTIVE: To determine the extent of unlicensed and off-label use of medicines in hospitalised children in the intensive care units of a tertiary care teaching hospital.
METHODS: A prospective, observational exploratory study was conducted on medicines prescribed to children admitted to the 3 intensive care units of Universiti Kebangsaan Malaysia Medical Centre (UKMMC).
RESULTS: A total of 194 patients were admitted to UKMMC, 168 of them received one or more drugs. Of 1,295 prescriptions, 353 (27.3 %) were unlicensed and 442 (34.1 %) were for off-label use. Forty-four percent of patients received at least one medicine for unlicensed use and 82.1 % received at least one medicine off-label. Preterm infants, children aged 28 days to 23 months, patients with hospital stays of more than 2 weeks, and those prescribed increasing numbers of medicines were more likely to receive medicines for unlicensed use. Term neonates and patients prescribed increasing numbers of medicines had increased risk of receiving medicines for off-label use.
CONCLUSION: Prescribing of medicines in an unlicensed or off-label fashion to the children in the intensive care units of UKMMC was common. Further detailed studies are necessary to ensure the delivery of safe and effective medicines to children.
METHODS: This single-center, retrospective, observational study included patients aged ≥18 years with an abdominal CT conducted within 72 hours of admission to the intensive care unit. SMI generated from CT images at the level of the mid-third lumbar vertebra were extracted from the medical records. Area under the receiver operating characteristic curves (AUC) was generated to determine the SMI cutoff values for hospital mortality. Association between LM (defined by SMI cutoff value) and hospital mortality was further evaluated by multivariable logistic regression.
RESULTS: In a sample of 228 patients, the overall SMI cutoff value (cm2 /m2 ) for hospital mortality was 42.0 (AUC: 0.637; sensitivity: 66.7%, specificity: 56.8%), whereas it was 46.5 in males and 35.3 in females. More males than females had LM (51.4% vs 37.5%), and >40% of overweight/obese patients had LM. Patients with LM were older and had a longer duration of mechanical ventilation and hospitalization. After adjusting for known confounders, LM independently predicted hospital mortality in the overall sample (adjusted odds ratio: 2.42; 95% CI 1.16-5.03; P = 0.003) and in both sexes.
CONCLUSION: This study established a set of SMI cutoff values that predict hospital mortality. LM is independently associated with hospital mortality.
DESIGN: A single-center retrospective cross-sectional study.
SETTING: Tertiary referral PICU in Johor, Malaysia.
PATIENTS: All children admitted to the PICU over 8 years were included. Patients readmitted into PICU after the first PICU discharge during the hospitalization period were categorized into "early" (within 48 hr) and "late" (after 48 hr), and factors linked to the readmissions were identified. The mortality rate was determined and compared between no, early, and late readmission.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: There were 2,834 patients in the study with 70 early and 113 late readmissions. Therefore, the rate of early and late PICU readmission was 2.5% (95% CI, 1.9-3.0%) and 3.9% (95% CI, 3.2-4.7%), respectively. The median length of stay of the second PICU admission for early and late readmissions was 2.7 days (interquartile range, 1.1-7.0 d) and 3.2 days (interquartile range, 1.2-7.5 d), respectively. The majority of early and late readmissions had a similar diagnosis with their first PICU admission. Multivariable multinomial logistic regression revealed a Pediatric Index Mortality 2 score of greater than or equal to 15, chronic cardiovascular condition, and oxygen supplement upon discharge as independent risk factors for early PICU readmission. Meanwhile, an infant of less than 1 year old, having cardiovascular, other congenital and genetic chronic conditions and being discharged between 8 AM and 5 PM was an independent risk factor for late readmission. There was no significant difference in the mortality rate of early (12.9%), late (13.3%), and no readmission (10.7%).
CONCLUSIONS: Despite the lack of resources and expertise in lower- and middle-income countries, the rate and factors for PICU readmission are similar to those in high-income countries. However, PICU readmission has no statistically significant association with mortality.
DESIGN: Single-center retrospective observational study.
SETTING: Thirty-six-bed surgical/medical tertiary PICU.
PATIENTS: Children from birth to less than or equal to 16 years old admitted between 2015 and 2018.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: Clinical data were extracted from the PICU clinical information system. Patients with baseline creatinine at admission greater than 20 micromol/L above the calculated normal creatinine level were classified as "high risk of acute kidney injury." Models were created to predict acute kidney injury at admission and on day 1. Out of the 7,505 children admitted during the study period, 738 patients (9.8%) were classified as high risk of acute kidney injury at admission and 690 (9.2%) developed acute kidney injury during PICU admission. Compared to Kidney Disease: Improving Global Outcomes criteria as the reference standard, high risk of acute kidney injury had a lower sensitivity and higher specificity compared with renal angina index greater than or equal to 8 on day 1. For the admission model, the adjusted odds ratio of developing acute kidney injury for high risk of acute kidney injury was 4.2 (95% CI, 3.3-5.2). The adjusted odds ratio in the noncardiac cohort for high risk of acute kidney injury was 7.3 (95% CI, 5.5-9.7). For the day 1 model, odds ratios for high risk of acute kidney injury and renal angina index greater than or equal to 8 were 3.3 (95% CI, 2.6-4.2) and 3.1 (95% CI, 2.4-3.8), respectively.
CONCLUSIONS: The relationship between high risk of acute kidney injury and acute kidney injury needs further evaluation. High risk of acute kidney injury performed better in the noncardiac cohort.
METHODS: Data of all infants admitted during the 2011-2012 period to the two hospitals at Singapore (SG) and Malaysia (MY) were pooled and analysed.
RESULTS: Of the 236 infants, SG infants received lower total protein and energy intake than MY infants (2.69 vs. 3.54 g/kg/day and 92.4 vs. 128.9 kcal/kg/day respectively; P -2 SDS (55 vs. 16%; P = 0.001). The greater use of a diuretic in SG to treat haemodynamically significant patent ductus arteriosus (hsPDA) may have contributed to the higher PNGF rate. Mean growth velocity of at least 15 g/kg/day was attained by VLBW infants only from Day 14 and by ELBW infants only from Day 28 post-natally. Overall, severe PNGF rates (z-score change >-2 SDS at 36 weeks' corrected age) were 28.8 and 36.5% for VLBW and ELBW infants, respectively.
CONCLUSIONS: Being very preterm, ELBW with hsPDA and receiving insufficient protein and energy were risk factors for severe PNGF. Increasing protein and energy content, augmenting fortification of breast milk and concentrating feed volumes, especially if there is an hsPDA, may curb severe PNGF among these infants.
METHODS AND ANALYSIS: PRoVENT-iMIC (study of PRactice of VENTilation in Middle-Income Countries) is an international multicentre observational study to be undertaken in approximately 60 ICUs in 11 Asian countries. Consecutive patients aged 18 years or older who are receiving invasive ventilation in participating ICUs during a predefined 28-day period are to be enrolled, with a daily follow-up of 7 days. The primary outcome is ventilatory management (including tidal volume expressed as mL/kg predicted body weight and positive end-expiratory pressure expressed as cm H2O) during the first 3 days of mechanical ventilation-compared between patients at no risk for acute respiratory distress syndrome (ARDS), patients at risk for ARDS and in patients with ARDS (in case the diagnosis of ARDS can be made on admission). Secondary outcomes include occurrence of pulmonary complications and all-cause ICU mortality.
ETHICS AND DISSEMINATION: PRoVENT-iMIC will be the first international study that prospectively assesses ventilation practices, outcomes and epidemiology of invasively ventilated patients in ICUs in Asia. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance when designing trials of invasive ventilation in resource-limited ICUs. Access to source data will be made available through national or international anonymised datasets on request and after agreement of the PRoVENT-iMIC steering committee.
TRIAL REGISTRATION NUMBER: NCT03188770; Pre-results.
DATA SOURCES: The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included.
RESULTS: A total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children was dose and age.
CONCLUSIONS: This review highlighted that off-label prescribing in children was found to be highly prevalent throughout the past two decades, persistently in the neonatal intensive care units. This suggests that besides legislative and regulatory initiatives, behavioural, knowledge aspects and efforts to integrate evidence into practice related to off-label prescribing also need to be evaluated and consolidated as part of the concerted efforts to narrow the gaps in prescribing for children.
METHODS: This is a retrospective review of all mechanically ventilated surgical patients in the wards, in a tertiary hospital, in 2020. Sixty-two patients out of 116 patients ventilated in surgical wards fulfilled the inclusion criteria. Demography, surgical diagnosis and procedures and physiologic, biochemical and survival data were analyzed to explore the outcomes and predictors of mortality.
RESULTS: Twenty-two out of 62 patients eventually gained ICU admission. Mean time from intubation to ICU entry and mean length of ICU stay were 48 h (0 to 312) and 10 days (1 to 33), respectively. Survival for patients admitted to ICU compared to ventilation in the acute surgery wards was 54.5% (12/22) vs 17.5% (7/40). Thirty-four patients underwent surgery, and the majority were bowel-related emergency operations. SAPS2 score validation revealed AUC of 0.701. More than half of patients with mortality risk care for critically ill surgical patients provides better survival. There is a need to improve triaging for intensive care, especially for low-mortality-risk patients using risk scores which are locally validated.
AIM: To determine the range of physical assessment skills practised by critical care nurses and their adoption factors.
STUDY DESIGN: This study uses a cross-sectional survey design. A self-administered questionnaire evaluating 40 physical assessment skills was conducted with 133 staff nurses (response rate: 96.4%) in three critical care units at a Malaysian government hospital between November 2019 and January 2020.
RESULTS: Most nurses applied 32 (80%) skills during every working shift, involving the vital signs and all body systems except the gastrointestinal system. Five skills (12.5%) were occasionally applied, while three skills (7.5%) were rarely applied or not part of most nurses' clinical practice. About 20% of the nurses did not routinely check the respiration rate. Medical and surgical intensive care unit nurses (U = 1129, p care settings challenges the assertion that physical assessment is vital to critical care nursing roles. Concerns highlighted by the nurses should be addressed by nursing management so that the application of physical assessment skills can be enhanced, especially in critical care settings.
RELEVANCE TO CLINICAL PRACTICE: The findings indicated that physical assessment skills in critical care need to be improved. Education and training should emphasise these skills.
METHODS AND ANALYSIS: This is a prospective direct observational study that will be conducted in five neonatal intensive care units. A minimum sample size of 820 drug preparations and administrations will be observed. Data including patient characteristics, drug preparation-related and administration-related information and other procedures will be recorded. After each round of observation, the observers will compare his/her observations with the prescriber's medication order, hospital policies and manufacturer's recommendations to determine whether MAE has occurred. To ensure reliability, the error identification will be independently performed by two clinical pharmacists after the completion of data collection for all study sites. Any disagreements will be discussed with the research team for consensus. To reduce overfitting and improve the quality of risk predictions, we have prespecified a priori the analytical plan, that is, prespecifying the candidate predictor variables, handling missing data and validation of the developed model. The model's performance will also be assessed. Finally, various modes of presentation formats such as a simplified scoring tool or web-based electronic risk calculators will be considered.