METHODS: This international, investigator-initiated, pragmatic, registry-based, single-blinded, randomised trial was undertaken in 85 intensive care units (ICUs) across 16 countries. We enrolled nutritionally high-risk adults (≥18 years) undergoing mechanical ventilation to compare prescribing high-dose protein (≥2·2 g/kg per day) with usual dose protein (≤1·2 g/kg per day) started within 96 h of ICU admission and continued for up to 28 days or death or transition to oral feeding. Participants were randomly allocated (1:1) to high-dose protein or usual dose protein, stratified by site. As site personnel were involved in both prescribing and delivering protein dose, it was not possible to blind clinicians, but patients were not made aware of the treatment assignment. The primary efficacy outcome was time-to-discharge-alive from hospital up to 60 days after ICU admission and the secondary outcome was 60-day morality. Patients were analysed in the group to which they were randomly assigned regardless of study compliance, although patients who dropped out of the study before receiving the study intervention were excluded. This study is registered with ClinicalTrials.gov, NCT03160547.
FINDINGS: Between Jan 17, 2018, and Dec 3, 2021, 1329 patients were randomised and 1301 (97·9%) were included in the analysis (645 in the high-dose protein group and 656 in usual dose group). By 60 days after randomisation, the cumulative incidence of alive hospital discharge was 46·1% (95 CI 42·0%-50·1%) in the high-dose compared with 50·2% (46·0%-54·3%) in the usual dose protein group (hazard ratio 0·91, 95% CI 0·77-1·07; p=0·27). The 60-day mortality rate was 34·6% (222 of 642) in the high dose protein group compared with 32·1% (208 of 648) in the usual dose protein group (relative risk 1·08, 95% CI 0·92-1·26). There appeared to be a subgroup effect with higher protein provision being particularly harmful in patients with acute kidney injury and higher organ failure scores at baseline.
INTERPRETATION: Delivery of higher doses of protein to mechanically ventilated critically ill patients did not improve the time-to-discharge-alive from hospital and might have worsened outcomes for patients with acute kidney injury and high organ failure scores.
FUNDING: None.
METHODS: A retrospective cohort study was performed between October 1st, 2018, and October 31st, 2020, in Farwaniya Hospital PICU, a 20-bed unit. All pediatric patients who were admitted to PICU and received systemic antimicrobials during the study period were included and followed until hospital discharge. The ASP team provided weekly prospective audit and feedback on antimicrobial use starting October 8th, 2019. A pediatric infectious diseases specialist joined the ASP rounds remotely. Descriptive analyses and a pre-post intervention comparison of days of therapy (DOT) were used to assess the effectiveness of the ASP intervention.
RESULTS: There were 272 and 156 PICU admissions received systemic antimicrobial before and after the initiation of ASP, respectively. Bronchiolitis and pneumonia were the most common admission diagnoses, together compromising 60.7% and 61.2% of cases pre- and post-ASP. The requirement for respiratory support was higher post-ASP (76.5% vs. 91.5%, p
MATERIALS: We recruited consecutively adult patients with SIRS admitted to an intensive care unit. They were divided into sepsis and noninfectious SIRS based on clinical assessment with or without positive cultures. Concentrations of PCT and IL-6 were measured daily over the first 3 days.
RESULTS: A total of 239 patients were recruited, 164 (68.6%) had sepsis, and 68 (28.5%) died in hospital. The PCT levels were higher in sepsis compared with noninfectious SIRS throughout the 3-day period (P < .0001). On admission, PCT concentration was diagnostic of sepsis (area under the curve of 0.63 [0.55-0.71]), and IL-6 was predictive of mortality, (area under the curve of 0.70 [0.62-0.78]). Peak IL-6 concentration improved the risk assessment of Sequential Organ Failure Assessment (SOFA) score for prediction of mortality among those who went on to die by an average of 5% and who did not die by 2%
CONCLUSIONS: Procalcitonin measured on intensive care unit admission was diagnostic of sepsis, and IL-6 was predictive of mortality. Addition of IL-6 concentration to SOFA score improved risk assessment for prediction of mortality. Future studies should include clinical indices, for example, SOFA score, for prognostic evaluation of biomarkers.
METHODS: This was a retrospective study of data from 37 NICUs in the Malaysian National Neonatal Registry in 2012. All newborns with gestational age ≥ 36 weeks, without major congenital malformations and fulfilling the criteria of HIE were included.
RESULTS: There were 285,454 live births in these hospitals. HIE was reported in 919 newborns and 768 of them were inborn, with a HIE incidence of 2.59 per 1,000 live births/hospital (95% confidence interval [CI] 2.03, 3.14). A total of 144 (15.7%) affected newborns died. Logistic regression analysis showed that the significant predictors of death were: chest compression at birth (adjusted odds ratio [OR] 2.27, 95% CI 1.27, 4.05; p = 0.003), being outborn (adjusted OR 2.65, 95% CI 1.36, 5.13; p = 0.004), meconium aspiration syndrome (MAS) (adjusted OR 2.16, 95% CI 1.05, 4.47; p = 0.038), persistent pulmonary hypertension of the newborn (PPHN) (adjusted OR 4.39, 95% CI 1.85, 10.43; p = 0.001), sepsis (adjusted OR 4.46, 95% CI 1.38, 14.40; p = 0.013), pneumothorax (adjusted OR 4.77, 95% CI 1.76, 12.95; p = 0.002) and severe HIE (adjusted OR 42.41, 95% CI 18.55, 96.96; p < 0.0001).
CONCLUSION: The incidence of HIE in Malaysian NICUs was similar to that reported in developed countries. Affected newborns with severe grade of HIE, chest compression at birth, MAS, PPHN, sepsis or pneumothorax, and those who were outborn were more likely to die before discharge.
OBJECTIVES: To present the protocol and analysis plan of a large randomised clinical trial investigating the effect of a sedation strategy, in critically ill patients who are mechanically ventilated, based on a protocol targeting light sedation using dexmedetomidine as the primary sedative, termed "early goal-directed sedation", compared with usual practice.
METHODS: This is a multinational randomised clinical trial in adult intensive care patients expected to require mechanical ventilation for longer than 24 hours. The main exclusion criteria include suspected or proven primary brain pathology or having already been intubated or sedated in an intensive care unit for longer than 12 hours. Randomisation occurs via a secured website with baseline stratification by site and suspected or proven sepsis. The primary outcome is 90-day all-cause mortality. Secondary outcomes include death, institutional dependency, cognitive function and health-related quality of life 180 days after randomisation, as well as deliriumfree, coma-free and ventilation-free days at 28 days after randomisation. A predefined subgroup analysis will also be conducted. Analyses will be on an intention-to-treat basis and in accordance with this pre-specified analysis plan.
CONCLUSION: SPICE III is an ongoing large scale clinical trial. Once completed, it will inform sedation practice in critically ill patients who are ventilated.
DESIGN: Prospective observational study.
SETTING: PICU in a tertiary care pediatric hospital.
PATIENTS: All English-literate parents whose child was admitted to our PICU between February 2014 and February 2015 were eligible after informed consent was obtained. Parents included in this study in previous admission(s) were excluded.
INTERVENTION: Nil.
MEASUREMENTS AND MAIN RESULTS: We adapted Empowerment of Parent in the Intensive Care Questionnaire, a validated questionnaire survey specific for measuring parental satisfaction in PICUs. This adapted survey consisted of 31 questions (based on a scale of 1-6) examining five domains as follows: information giving, care and cure, parental participation, organization, and professional attitude. Reliability of Empowerment of Parent in the Intensive Care Questionnaire in our population was analyzed using Cronbach's alpha. We used ordinal logistic regression, controlling for socioeconomic status and educational level, to examine differences in parental perceptions of various ethnicities. We obtained a total of 206 responses (36.5%) from 543 admissions. There were 116 (56%) emergency and 90 (44%) elective admissions. The proportion of respondents were Chinese (126 [61%]), Malay (32 [16%]), Indian (23 [11%]), and "Others" (25 [12%]). Cronbach's alpha for domains of information giving (α = 0.80), care and cure (α = 0.93), parental participation (α = 0.84), organization (α = 0.79), and professional attitude (α = 0.88) were good. In all five domains, our median PICU scores were 6 (interquartile range, 5-6). Compared to other ethnic groups, Malay parents did perceive that domains of "care and cure," "parental participation," and "professional attitude" were less satisfactory.
CONCLUSIONS: Significant differences were found in satisfaction ratings between parents of different ethnicities. Further studies are needed to explore and determine reasons for these differences.
METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.
RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13).
CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.
Methods: A total of 110 severe TBI patients, aged 18-60, who underwent emergency brain surgery were randomised into Group T (TCI) (n = 55) and Group S (sevoflurane) (n = 55). Anaesthesia was maintained in Group T with propofol target plasma concentration of 3-6 μg/mL and in Group S with minimum alveolar concentration (MAC) of sevoflurane 1.0-1.5. Both groups received TCI remifentanil 2-8 ng/mL for analgesia. After the surgery, patients were managed in the intensive care unit and were followed up until discharge for the outcome parameters.
Results: Demographic characteristics were comparable in both groups. Differences in Glasgow Outcome Scale (GOS) score at discharge were not significant between Group T and Group S (P = 0.25): the percentages of mortality (GOS 1) [27.3% versus 16.4%], vegetative and severe disability (GOS 2-3) [29.1% versus 41.8%] and good outcome (GOS 4-5) [43.6% versus 41.8%] were comparable in both groups. There were no significant differences in other outcome parameters.
Conclusion: TCI propofol and sevoflurane anaesthesia were comparable in the outcomes of TBI patients after emergency surgery.