Intensive Care Unit Network Research Articles

Nirsevimab Effectiveness Against Cases of Respiratory Syncytial Virus Bronchiolitis Hospitalised in Paediatric Intensive Care Units in France, September 2023-January 2024.

In September 2023, France was one of the first countries that started a national immunisation campaign with nirsevimab, a new monoclonal antibody against respiratory syncytial virus (RSV). Using data from a network of paediatric intensive care units (PICUs), we aimed to estimate nirsevimab effectiveness against severe cases of RSV bronchiolitis in France. We conducted a case-control study based on the test-negative design and included 288 infants reported by 20 PICUs. We estimated nirsevimab effectiveness at 75.9% (48.5-88.7) in the main analysis and 80.6% (61.6-90.3) and 80.4% (61.7-89.9) in two sensitivity analyses. These real-world estimates confirmed the efficacy observed in clinical studies.

Acute kidney injury in acute decompensated heart failure related cardiogenic shock: data from the Alt-Shock2 registry

Abstract Funding Acknowledgements None. Background Acute kidney injury (AKI) is one of the most common complications in patients with cardiogenic shock (CS), proving the strict relationship between heart and kidney (the so-called cardio-renal syndrome). AKI is a marker of shock severity, but also independently associated with worse outcomes. Purpose Many data are available on the prevalence of AKI in acute heart failure, but very few studies assessed the role of AKI in CS and they were mainly focused on acute myocardial infarction (AMI)-related CS. Aim of our study was to analyze the impact of AKI on acute decompensated heart failure (ADHF)-CS. Methods Between March 2020 and August 2022, we prospectively enrolled 375 CS patients from a Cardiac Intensive Care Units Network of 12 centers. Among these patients 121 (33.9% of the whole cohort) with ADHF-CS were included for the present analysis. AKI was defined according to KDIGO 2012 criteria as serum creatinine increase ≥ 0.3 mg/dl or 1.5 times compared to admission value, or urinary output < 0.5 ml/kg/h. Results Table 1 shows the baseline characteristics of the cohort. Patients with AKI were older (70 years old [55.5; 76] vs 61 [54; 69], p<0.05), had more comorbidities and a worse CS profile on admission. On multivariable analysis, SCAI stage D-E on admission was independently associated with a higher risk of AKI 24 hours after admission (OR 5.54 and p = 0.01). Treatment with mechanical circulatory support did not prevent AKI (OR 0.84 and p = 0.8). Notably, patients with a greater reduction in central venous pressure (CVP) 24 hours after admission had a lower risk of AKI (deltaCVP in AKI group 0 [-3;0] versus deltaCVP in no-AKI group -3 [-6;0], p = 0.025). Kaplan-Meier curves showed significantly worse survival in patients with AKI (Figure 1A). Cox regression analysis confirmed an association between AKI and increased risk of death (HR 2.14, CI 95% 1.16-3.96, p = 0.01). Notably, this association was even more pronounced in patients with SCAI stages A-B-C (HR 2.81, CI 95% 1.30-6.09, p = 0.01). Finally, in patients treated with renal replacement therapy (RRT) there was no association with lower survival at 180-days follow up (Figure 1B). Conclusions Our study confirms that AKI is a predictor of adverse outcomes in patients with ADHF-CS. Effective decongestion 24 hours after admission was associated with a lower risk of AKI. Considering that AKI had a negative impact even at lower SCAI stages, our findings underscore the importance of early identification of renal injury to promptly target decongestion with pharmacologic therapy and, ultimately, early use of RRT.

De-escalating treatments and transitioning care in a cardiac intensive care units network

Abstract Funding Acknowledgements None. Background Recent data (1) have shown that end-of-life (EOL) management of patients with acute decompensated heart failure (ADHF) in Cardiac Intensive Care Units (CICU) is aggressive, with late or no involvement of palliative care (PC) teams. Purpose To evaluate current PC and EOL practices in a contemporary multicenter registry of patients with ADHF who deteriorated to cardiogenic shock (CS). Methods A survey-based approach was used to collect data on PC and EOL management practices. We enrolled CS patients from 12 participating centers. A subset of 153 patients with ADHF-CS, enrolled between March 2020 and March 2023, was analyzed. We asked participating centers to report their practice regarding de-escalating treatments and transitioning care in the context of EOL, focusing on 1) discussion of implantable cardioverter defibrillator (ICD) deactivation with patients, 2) documentation of do-not-resuscitate (DNR) orders in the patient's medical record, and 3) documentation of advance directives in the patient's medical record. We also examined early PC team involvement and ICD deactivation as indicators of de-escalating treatments and transitional care in ADHF-CS. Results are presented as numbers and percentages (%) for categorical variables and medians (interquartile range, IQR) for continuous variables. Results Baseline characteristics of the population are shown in Table 1. Figure 1 describes the practices of the participating centers. DNR was routinely documented in the medical records in only 5 of 12 centers (41.7%). PC teams were involved in 21 of 153 enrolled ADHF-CS patients (13.7%). Of the 51 patients with an ICD, 17 died: 13 patients (76%) died in the hospital and 4 (24%) died within 6 months of discharge. ICD deactivation occurred in 6 of 17 deceased patients (35.3%). One patient had ICD deactivation supported by home PC services. Conclusions This study shows that the practice of de-escalating therapy, including ICD deactivation, is not routine in the participating centers. Our findings highlight the importance of integrating PC as a concurrent process with intensive care to effectively address the unmet needs of these patients and their families.

Job description and perception of clinical research personnel working in a network of French intensive care units

BackgroundThere is a lack of information about the organisation and management of clinical research personnel in Europe and of their professional activity in intensive care. We therefore conducted a cross-sectional survey among personnel currently working in a French intensive care research network that involves 41 centres nationwide. The aim of the survey was to describe the personnel’s personal and institutional organisation and management, their job perception in terms of satisfaction and stress, and suggestions for improvement.MethodsOver 3 months in 2023, the research personnel received an electronic questionnaire on their personal and professional profile, past and present training, workplace and functions currently performed, personal knowledge about job skills required, job satisfaction and stress by as measured on a rating scale, and suggested ways of improvement.ResultsNinety seven people replied to the questionnaire (a response rate of 71.3%), of whom 78 (57.3%) were sufficiently involved in intensive care to provide complete answers. This core sample had profiles in line with French recruitment policies and comprised mainly Bachelor/Master graduates, with nurses accounting for only 21.8%. The female to male ratio was 77:23%. Many responders declared to have a shared activity of technician (for investigation) and assistant (for quality control). More than 70% of the responders considered that most of the tasks required of each worker were major. Figures were much lower for project managers, who were few to take part in the survey. On a scale of 10, the median of job satisfaction was 7 for personal work organisation, 6 for training and for institutional organisation, and only 5 for personal career management. The median of job stress was 5 and was inversely correlated with satisfaction with career management. Respect of autonomy, work-sharing activity between investigation and quality control, a better career progression, financial reward for demanding tasks, and participation in unit staff meetings were the main suggestions to improve employee satisfaction.ConclusionThis nationwide survey provides a new insight into the activity of French clinical research personnel and points to ways to improve the quality and efficiency of this workforce.

The Combined Contributions of Newborn Stress and Parenting Stress on Toddler Language Development

ObjectiveTo examine the longitudinal associations between newborn neurobehavioral stress signs, maternal parenting stress, and several indices of toddler language development. Study designParticipants include 202 mother-infant dyads (104 girls). We measured stress signs in neonates in the hospital at least 24 hours after birth using the Neonatal Intensive Care Unit Network Neurobehavioral Scale. At 7 months, parenting stress (competence, attachment, and role restriction) was assessed using the Parenting Stress Index. At 18 months, mothers completed the Communicative Development Inventories, which measured toddler gesturing, expressive vocabulary, and receptive vocabulary. Longitudinal path modeling was used to estimate associations between neonatal stress signs, parenting stress, and toddler language, and a model was generated for each language outcome. Child sex, birth weight, and family income were included as covariates. ResultsInfants who exhibited greater neurobehavioral stress signs at birth produced significantly fewer social-communicative gestures at 18-months of age. Among infants whose mothers reported low (but not high) levels of parenting stress during the first postnatal year, newborn stress signs were negatively associated with 18-month-olds’ receptive vocabulary size. Neither newborn stress signs nor parenting stress were significantly related to toddler expressive vocabulary size. ConclusionsOur findings uncover a negative association between newborn stress signs and toddler gesturing. Furthermore, our results suggest that caregiver stress and neonatal stress signs interact to predict toddler receptive vocabulary. Taken together, these results demonstrate that some neonates who exhibit increased neurobehavioral stress signs may be at heightened risk for experiencing language difficulties. These children may benefit from additional support in infancy.

Modes of Death in Patients with Cardiogenic Shock in the Cardiac Intensive Care Unit: A Report from the Critical Care Cardiology Trials Network

BackgroundThere are limited data on how patients with cardiogenic shock (CS) die. MethodsThe Critical Care Cardiology Trials Network is a research network of cardiac intensive care units coordinated by the Thrombolysis In Myocardial Infarction (TIMI) Study Group (Boston, MA). Using standardized definitions, site investigators classified direct modes of in-hospital death for CS admissions (October 2021 to September 2022). Mutually exclusive categories included 4 modes of cardiovascular death and 4 modes of noncardiovascular death. Subgroups defined by CS type, preceding cardiac arrest (CA), use of temporary mechanical circulatory support (tMCS), and transition to comfort measures were evaluated. ResultsAmong 1068 CS cases, 337 (31.6%) died during the index hospitalization. Overall, the mode of death was cardiovascular in 82.2%. Persistent CS was the dominant specific mode of death (66.5%), followed by arrhythmia (12.8%), anoxic brain injury (6.2%), and respiratory failure (4.5%). Patients with preceding CA were more likely to die from anoxic brain injury (17.1% vs 0.9%; P < .001) or arrhythmia (21.6% vs 8.4%; P < .001). Patients managed with tMCS were more likely to die from persistent shock (P < .01), both cardiogenic (73.5% vs 62.0%) and noncardiogenic (6.1% vs 2.9%). ConclusionsMost deaths in CS are related to direct cardiovascular causes, particularly persistent CS. However, there is important heterogeneity across subgroups defined by preceding CA and the use of tMCS.

Prognostic performance of the IABP-SHOCK II Risk Score among cardiogenic shock subtypes in the critical care cardiology trials network registry

BackgroundRisk stratification has potential to guide triage and decision-making in cardiogenic shock (CS). We assessed the prognostic performance of the IABP-SHOCK II score, derived in Europe for acute myocardial infarct-related CS (AMI-CS), in a contemporary North American cohort, including different CS phenotypes. MethodsThe Critical Care Cardiology Trials Network (CCCTN) coordinated by the TIMI Study Group is a multicenter network of cardiac intensive care units (CICU). Participating centers annually contribute ≥2 months of consecutive medical CICU admissions. The IABP-SHOCK II risk score includes age >73 years, prior stroke, admission glucose >191 mg/dl, creatinine >1.5 mg/dl, lactate >5 mmol/l, and post-PCI TIMI flow grade <3. We assessed the risk score across various CS etiologies. ResultsOf 17,852 medical CICU admissions 5,340 patients across 35 sites were admitted with CS. In patients with AMI-CS (n=912), the IABP-SHOCK II score predicted a >3-fold gradient in in-hospital mortality (low risk = 26.5%, intermediate risk =52.2%, high risk = 77.5%, p<0.0001; c-statistic=0.67; Hosmer-Lemeshow p=0.79). The score showed a similar gradient of in-hospital mortality in patients with non-AMI-related CS (n=2,517, p<0.0001) and mixed shock (n=923, p<0.001), as well as in left ventricular (<0.0001), right ventricular (p = 0.0163) or biventricular (<0.0001) CS. The correlation between the IABP-SHOCK II score and SOFA was moderate (r2=0.17) and the IABP-SHOCK II score revealed a significant risk gradient within each SCAI Stage. ConclusionsIn an unselected international multicenter registry of patients admitted with CS, the IABP- SHOCK II score only moderately predicted in-hospital mortality in a broad population of CS regardless of etiology or irrespective of right, left, or bi-ventricular involvement.

Health disparities in preterm births.

Black African American (B/AA) women have a 2-fold to 3-fold elevated risk compared with non-Hispanic White (W) women for preterm birth. Further, preterm birth is the leading cause of mortality among B/AA infants, and among survivors, preterm infant adverse health outcomes occur disproportionately in B/AA infants. Racial inequities in maternal and infant health continue to pose a public health crisis despite the discovery >100 years ago. The purpose of this study was to expand on reported preterm infant outcome disparities. A life-course approach, accumulation of lifelong stress, including discrimination, may explain social factors causing preterm birth rate and outcome inequities in B/AA mothers. Anthropometric measures and clinical treatment information for 197 consented participants were milled from electronic health records across 4 years. The Neonatal Infant Stressor Scale was used to tally acute and chronic painful/stressful procedures. Neurobehavioral differences were investigated using the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale. B/AA mothers gave birth to preterm infants earlier than W mothers. NICU hospitalization stays were extended more than 2 weeks for the significantly smaller B/AA preterm infants in comparison to the age-matched W preterm infants. A higher number of chronic lifesaving procedures with demonstrated altered stress response patterns were recorded for B/AA preterm infants. This cross-sectional analysis of preterm birth rates and preterm infant developmental and neurodevelopmental outcomes are presented in the context of NICU stress and pain, with attendant implications for infant mortality and future health disparities. Preterm birth rate and outcome inequities further support the need to develop interventions and policies that will reduce the impact of discrimination and improve social determinants of health for Black, Indigenous, and other People of Color.

Early neurobehavioral outcomes in infants with suspected abusive head trauma: Performance across and relationship between measures

Early neurobehavioral outcomes among infants with abusive head trauma (AHT) have not been well characterized. Though there are standardized measures for assessing infants, the ability of these measures to detect deficits may be limited. The Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale, Second Edition (NNNS-II) has been correlated with neurobehavioral outcomes as early as birth but has not been used with this clinical group. There is no strong evidence of the concurrent validity of this measure. The primary goal was to examine the concurrent validity of the NNNS-II in patients with suspected AHT by comparing it to the Mullen Scales of Early Learning, American Guidance Service (AGS) Edition (Mullen). A secondary goal was to characterize early neurobehavioral outcomes among infants with suspected AHT across two measures. This retrospective study included 11 infants who sustained a traumatic brain injury (TBI) around 40 days of age. The sample’s performance was variable and ranged from average to below average across measures. Participants experienced the most difficulty with visuospatial processing, attentional abilities, physiologic regulation, and asymmetric reflexes, and data suggested the NNNS-II may be more sensitive to deficits. There was evidence of concurrent validity of the NNNS-II based on strong to moderate correlations with the Mullen. Use of the NNNS-II shortly after the injury is more likely to showcase deficits, which may increase the likelihood that patients receive early intervention. Establishing concurrent validity of the NNNS-II further contributes to the evidence base regarding its criterion related validity, which may promote its more regular use.

Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial

PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for “sedation, analgesia and delirium” (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395–8.358), “ventilation” (OR 2.248, 1.198–4.217), “weaning from ventilation” (OR 9.049, 2.707–30.247), “infection management” (OR 4.397, 1.482–13.037), “enteral nutrition” (OR 1.579, 1.032–2.416), “patient and family communication” (OR 6.787, 3.976–11.589), and "early mobilisation" (OR 3.161, 2.160–4.624). No evidence for a difference in adherence to “daily multi-professional and interdisciplinary clinical visits” between both conditions was found (OR 1.606, 0.780–3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

Variation in hospital morbidities in an Australian neonatal intensive care unit network

ObjectiveThere is an expectation among the public and within the profession that the performance and outcome of neonatal intensive care units (NICUs) should be comparable between centres with a similar...

Analysis of Neonatal Neurobehavior and Developmental Outcomes Among Preterm Infants

The ability to identify poor outcomes and treatable risk factors among very preterm infants remains challenging; improving early risk detection and intervention targets to potentially address developmental and behavioral delays is needed. To determine associations between neonatal neurobehavior using the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS), neonatal medical risk, and 2-year outcomes. This multicenter cohort enrolled infants born at less than 30 weeks' gestation at 9 US university-affiliated NICUs. Enrollment was conducted from April 2014 to June 2016 with 2-year adjusted age follow-up assessment. Data were analyzed from December 2019 to January 2022. Adverse medical and psychosocial conditions; neurobehavior. Bayley Scales of Infant and Toddler Development, third edition (Bayley-III), cognitive, language, and motor scores of less than 85 and Child Behavior Checklist (CBCL) T scores greater than 63. NNNS examinations were completed the week of NICU discharge, and 6 profiles of neurobehavior were identified by latent profile analysis. Generalized estimating equations tested associations among NNNS profiles, neonatal medical risk, and 2-year outcomes while adjusting for site, maternal socioeconomic and demographic factors, maternal psychopathology, and infant sex. A total of 679 enrolled infants had medical and NNNS data; 2-year follow-up data were available for 479 mothers and 556 infants (mean [SD] postmenstrual age at birth, 27.0 [1.9] weeks; 255 [45.9%] female). Overall, 268 mothers (55.9%) were of minority race and ethnicity, and 127 (26.6%) lived in single-parent households. The most common neonatal medical morbidity was BPD (287 [51.7%]). Two NNNS behavior profiles, including 157 infants, were considered high behavioral risk. Infants with at least 2 medical morbidities (n = 123) were considered high medical risk. Infants with high behavioral and high medical risk were 4 times more likely to have Bayley-III motor scores less than 85 compared with those with low behavioral and low medical risk (adjusted relative risk [aRR], 4.1; 95% CI, 2.9-5.1). Infants with high behavioral and high medical risk also had increased risk for cognitive scores less than 85 (aRR, 2.7; 95% CI, 1.8-3.4). Only infants with high behavioral and low medical risk were in the clinical range for CBCL internalizing and total problem scores (internalizing: aRR, 2.3; 95% CI, 1.1-4.5; total: aRR, 2.5; 95% CI, 1.2-4.4). In this study, high-risk neonatal neurobehavioral patterns at NICU discharge were associated with adverse cognitive, motor, and behavioral outcomes at 2 years. Used in conjunction with medical risk, neonatal neurobehavioral assessments could enhance identification of infants at highest risk for delay and offer opportunities to provide early, targeted therapies.

Performance evaluation of a multinational data platform for critical care in Asia

Background: The value of medical registries strongly depends on the quality of the data collected. This must be objectively measured before large clinical databases can be promoted for observational research, quality improvement, and clinical trials. We aimed to evaluate the quality of a multinational intensive care unit (ICU) network of registries of critically ill patients established in seven Asian low- and middle-income countries (LMICs). Methods: The Critical Care Asia federated registry platform enables ICUs to collect clinical, outcome and process data for aggregate and unit-level analysis. The evaluation used the standardised criteria of the Directory of Clinical Databases (DoCDat) and a framework for data quality assurance in medical registries. Six reviewers assessed structure, coverage, reliability and validity of the ICU registry data. Case mix and process measures on patient episodes from June to December 2020 were analysed. Results: Data on 20,507 consecutive patient episodes from 97 ICUs in Afghanistan, Bangladesh, India, Malaysia, Nepal, Pakistan and Vietnam were included. The quality level achieved according to the ten prespecified DoCDat criteria was high (average score 3.4 out of 4) as was the structural and organizational performance -- comparable to ICU registries in high-income countries. Identified strengths were types of variables included, reliability of coding, data completeness and validation. Potential improvements included extension of national coverage,optimization of recruitment completeness validation in all centers and the use of interobserver reliability checks. Conclusions: The Critical Care Asia platform evaluates well using standardised frameworks for data quality and equally to registries in resource-rich settings.

FC 127: Acute Kidney Injury and Exposure to Nephrotoxic Drugs in Critically Ill Patients: A Report From the Multicenter Rescue Project in the Netherlands

Abstract BACKGROUND AND AIMS Acute kidney injury (AKI) is a common problem in patients admitted to the intensive care unit (ICU). Nephrotoxic drugs play a causal role in 14–28% of the ICU AKI cases and are one of the few preventable AKI causes. The Dutch multicenter project ‘Towards a leaRning mEdication Safety system in a national network of Intensive Care Units—timely detection of adverse drug Events’ (RESCUE) aims to improve medication safety in ICU patients with respect to drug-induced AKI. This requires knowledge on which drugs may cause AKI and the strength of their effects. Obtaining such knowledge is challenging due to confounding. Especially in the ICU, where patients often have multiple comorbidities, AKI risk factors may also be indications or contraindications for drugs. We aimed to estimate the independent associations between nephrotoxic drug groups and AKI in ICU patients by adjusting for drug group-specific confounders. METHOD We used a detailed electronic health record database of ICU patients admitted to 13 different ICUs between 2010 and 2019 in the Netherlands. The database contains admission characteristics, (chronic) comorbidities, physiology measurements, Acute Physiology and Chronic Health Evaluation IV admission diagnoses and predicted mortality probabilities, serum creatinine (SCr), drug administrations, arterial blood pressure and renal replacement therapy (RRT) treatments. We included admissions with at least two SCr values and excluded admissions with one or more missing AKI risk factor values. Using the Kidney Disease: Improving Global Outcomes Clinical Practice Guideline for Acute Kidney Injury, we diagnosed and staged AKI according to the SCr and RRT criteria. We recorded exposure to eight drug groups widely regarded as acutely nephrotoxic [1] until AKI onset, discharge or death. Multilevel logistic regression models were applied to estimate the independent association between each drug group and AKI. The estimates were adjusted for drug group-specific confounders: we registered which AKI risk factors were indications or contraindications for each drug group. RESULTS We included 98 391 ICU admissions, of which 14 074 (14%) were diagnosed with AKI, ranging between 6 and 21% across the ICUs. Of all admissions with AKI, 8962 (64%), 1283 (9%) and 3829 (27%) developed AKI stage 1, stage 2 or stage 3, respectively (Figure 1). The percentage of admissions exposed to nephrotoxic drug groups was 7% for aminoglycosides, 6% for nonsteroidal anti-inflammatory drugs (NSAIDs), 6% for penicillin combinations, 5% for glycopeptide antibiotics, 2% for sulfonamides, 2% for antivirals for herpes infections, 1% for immunosuppressants and 1% for antimycotic antibiotics. All drug groups were associated with a higher odds of AKI except NSAIDs and penicillin combinations (Table 1). While penicillin combinations were not associated with AKI, NSAIDs were associated with a lower odds of AKI. The drug groups with the highest odds of AKI were immunosuppressants [odds ratio (OR) 2.26, 95% confidence interval (95% CI) 1.97–2.60; P &amp;lt; 0.001), sulfonamides (OR 1.84, 95% CI 1.65–2.04; P &amp;lt; 0.001) and aminoglycosides (OR 1.70, 95% CI 1.59–1.81; P &amp;lt; 0.001). The NSAID group was the only group that showed a higher OR after adjustment. CONCLUSION We estimated the independent associations between nephrotoxic drug groups and AKI by adjusting for drug-group specific confounders. Our results provide new estimates of the strengths of the associations. Surprisingly, NSAIDs were associated with a lower odds of AKI. This association might be biased due to residual confounding by contraindication. Future studies may investigate strategies to avoid drug-induced AKI.

Neonatal Intensive Care Unit Network Neurobehavioral Scale Profiles in Full-Term Infants: Associations with Maternal Adversity, Medical Risk, and Neonatal Outcomes

To examine healthy, full-term neonatal behavior using the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) in relation to measures of maternal adversity, maternal medical risk, and infant brain volumes. This was a prospective, longitudinal, observational cohort study of pregnant mothers followed from the first trimester and their healthy, full-term infants. Infants underwent an NNNS assessment and high-quality magnetic resonance imaging 2-5weeks after birth. A latent profile analysis of NNNS scores categorized infants into neurobehavioral profiles. Univariate and multivariate analyses compared differences in maternal factors (social advantage, psychosocial stress, and medical risk) and neonatal characteristics between profiles. The latent profile analysis of NNNS summary scales of 296 infants generated 3 profiles: regulated (46.6%), hypotonic (16.6%), and fussy (36.8%). Infants with a hypotonic profile were more likely to be male (χ2=8.601; P=.014). Fussy infants had smaller head circumferences (F=3.871; P=.022) and smaller total brain (F=3.522; P=.031) and cerebral white matter (F=3.986; P=.020) volumes compared with infants with a hypotonic profile. There were no differences between profiles in prenatal maternal health, social advantage, or psychosocial stress. Three distinct neurobehavioral profiles were identified in healthy, full-term infants with hypotonic and fussy neurobehavioral features related to neonatal brain volumes and head circumference, but not prenatal exposure to socioeconomic or psychosocial adversity. Follow-up beyond the neonatal period will determine if identified profiles at birth are associated with subsequent clinical or developmental outcomes.

Contribution of Concurrent Comorbidities to Sepsis-Related Mortality in Preterm Infants ≤32 Weeks of Gestation at an Academic Neonatal Intensive Care Network.

This study sought to identify concurrent major comorbidities in preterm infants ≤32 weeks of gestation that may have contributed to sepsis-related mortality following a diagnosis of bacteremia or blood culture-negative sepsis within the neonatal period (≤28 days of life). This is a retrospective chart review of infants ≤32 weeks of gestation who were admitted to a single academic network of multiple neonatal intensive care units between January 1, 2012, and December 31, 2015, to determine the primary cause(s) and timing of death in those diagnosed with bacteremia or blood culture-negative sepsis. Direct comparisons between early-onset sepsis (EOS; ≤72 hours) and late-onset sepsis (LOS; >72 hours) were made. In our study cohort, of 939 total patients with ≤32 weeks of gestation, 182 infants were diagnosed with 198 episodes of sepsis and 7.7% (14/182) died. Mortality rates did not significantly differ between neonates with bacteremia or blood culture-negative sepsis (7/14 each group), and those diagnosed with EOS compared with LOS (6/14 vs. 8/14). Nearly 80% (11/14) of infants were transitioned to comfort care prior to their death secondary to a coinciding diagnosis of severe grade-3 or -4 intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, and/or intestinal perforation. Preexisting comorbidities commonly associated with extreme preterm birth contributed to sepsis-related mortality in our patient cohort. · Concurrent comorbidities contribute to, and may artificially inflate, sepsis-related mortality.. · Absence of a consensus definition for neonatal sepsis complicates the investigation of infection.. · Accurate assessment of the incidence of sepsis in very low birth weight infants is vital for future investigations..

Performance evaluation of a multinational data platform for critical care in Asia

Background: The value of medical registries strongly depends on the quality of the data collected. This must be objectively measured before large clinical databases can be promoted for observational research, quality improvement, and clinical trials. We aimed to evaluate the quality of a multinational intensive care unit (ICU) network of registries of critically ill patients established in seven Asian low- and middle-income countries (LMICs). Methods: The Critical Care Asia federated registry platform enables ICUs to collect clinical, outcome and process data for aggregate and unit-level analysis. The evaluation used the standardised criteria of the Directory of Clinical Databases (DoCDat) and a framework for data quality assurance in medical registries. Six reviewers assessed structure, coverage, reliability and validity of the ICU registry data. Case mix and process measures on patient episodes from June to December 2020 were analysed. Results: Data on 20,507 consecutive patient episodes from 97 ICUs in Afghanistan, Bangladesh, India, Malaysia, Nepal, Pakistan and Vietnam were included. The quality level achieved according to the ten prespecified DoCDat criteria was high (average score 3.4 out of 4) as was the structural and organizational performance -- comparable to ICU registries in high-income countries. Identified strengths were types of variables included, reliability of coding, data completeness and validation. Potential improvements included extension of national coverage, optimization of recruitment completeness validation in all centers and the use of interobserver reliability checks. Conclusions: The Critical Care Asia platform evaluates well using standardised frameworks for data quality and equally to registries in resource-rich settings.

Abstract 14409: Elucidating Clinical Phenotypes of Patients With Mixed Shock Admitted to Cardiac Intensive Care Units: Insights From the Critical Care Cardiology Trials Network

Background: Emerging data suggests that patient with mixed cardiogenic and vasodilatory shock have high morbidity and mortality; however, this population is still poorly understood and is not well-characterized. Methods: The Critical Care Cardiology Trials Network is a multicenter network of advanced cardiac intensive care units (CICUs) in North America coordinated by the TIMI Study Group. Each CICU contributed an annual 2-month period of all consecutive medical CICU admissions from 2017-2020 (n=13,300). Mixed shock (MS) subjects were stratified into those with acute MI (AMI-MS) and those without (non-AMI-MS). Results: Among 3884 CICU admissions with shock, 840 (22%) presented with MS; 169 AMI-MS and 671 non-AMI-MS. Mean age was 66y, 37.1% were female, and 69.5% were white. Median Sequential Organ Failure Assessment was 10.0 (25 th -75 th %ile, 7.0-12.5). On presentation, AMI-MS had more end-organ injury: lactate (3.5 vs. 2.7, p &lt; 0.01) &amp; AST (126 vs. 54, p &lt; 0.01). AMI-MS had fewer CV &amp; non-CV comorbidities ( p &lt; 0.01 for all). Sepsis was less common in AMI-MS (47.8% vs. 67.6%, p &lt; 0.0001). Use of advanced ICU therapies was high, as 25.4% overall cohort required renal replacement therapy (RRT). AMI-MS required more mechanical ventilation (81.1% vs. 67.5%, p &lt; 0.001), invasive cardiac procedures (76.3% vs. 16.2%, p &lt; 0.0001), and temporary mechanical support (tMCS) (56.8% vs. 16.7%, p &lt; 0.0001). Both AMI-MS and non-AMI-MS patients had high in-hospital mortality (50.3% [95% CI 42.5% - 58.1%] &amp; 43.5% [95% CI 39.7% - 47.4%], respectively). AMI-MS patients with a worst pH &lt; 7.25, ≥ 3 pressors, and RRT use have a 4.9-fold, 3.9-fold, and 2.9-fold risk of in-hospital mortality, respectively (Figure). Conclusion: In a contemporary multicenter analysis of advanced CICUs, patients with mixed shock have high in-hospital mortality and frequent need for advanced ICU therapies. Patients with AMI-MS present with particularly high shock severity and subsequent resource utilization.

Potential benefit from the implementation of the Kaiser Permanente neonatal early-onset sepsis calculator on clinical management of neonates with presumed sepsis.

To assess the potential benefit from the implementation of the Kaiser Permanente early-onset sepsis calculator (EOS-C), in terms of antibiotic use and requested laboratory tests, in a network of neonatal intensive care units (NICUs) in Greece, and to determine the incidence of early-onset sepsis (EOS) in Greek NICUs, a prospective surveillance study was conducted in 7 NICUs between April 2018 and June 2019. Data were collected for all newborns ≥ 34weeks' gestation receiving empiric antibiotic therapy within the first 3days of life. The number of live births and positive blood or cerebrospinal fluid cultures within the first 3days of life were used for calculation of EOS incidence. Evaluation of possible impact of implementing the calculator was done by comparing the clinicians' recorded management to the calculator's suggested course of action. The unit-specific incidence of culture-proven EOS ranged between 0 and 2.99/1000 live births. The weighted incidence rate for all 7 units was 1.8/1000 live births. Management of EOS guided by the calculator could lead to a reduction of empiric antibiotic initiation up to 100% for the group of "well-appearing" neonates and 86% for "equivocal," lowering exposure to antibiotics by 4.2 and 3.8days per neonate, respectively. Laboratory tests for blood cultures drawn could be reduced by up to 100% and 68%, respectively. Sensitivity of the EOS-C in identifying neonates with positive blood cultures was high.Conclusion: Management strategies based on the Kaiser Permanente neonatal sepsis calculator may significantly reduce antibiotic exposure, invasive diagnostic procedures, and hospitalizations in late preterm and term neonates. What is Known: • Neonates are frequently exposed to antibiotics for presumed EOS. • The Kaiser Permanente sepsis calculator can reduce antibiotic exposure in neonates.. What is New: • EOS calculator can be an effective antibiotic stewardship tool in a high prescribing country and can reduce invasive diagnostic procedures and mother-baby separation. • Incidence of EOS in Greece is higher compared to other European countries.

Performance evaluation of a multinational data platform for critical care in Asia.

Background: The value of medical registries strongly depends on the quality of the data collected. This must be objectively measured before large clinical databases can be promoted for observational research, quality improvement, and clinical trials. We aimed to evaluate the quality of a multinational intensive care unit (ICU) network of registries of critically ill patients established in seven Asian low- and middle-income countries (LMICs). Methods: The Critical Care Asia federated registry platform enables ICUs to collect clinical, outcome and process data for aggregate and unit-level analysis. The evaluation used the standardised criteria of the Directory of Clinical Databases (DoCDat) and a framework for data quality assurance in medical registries. Six reviewers assessed structure, coverage, reliability and validity of the ICU registry data. Case mix and process measures on patient episodes from June to December 2020 were analysed. Results: Data on 20,507 consecutive patient episodes from 97 ICUs in Afghanistan, Bangladesh, India, Malaysia, Nepal, Pakistan and Vietnam were included. The quality level achieved according to the ten prespecified DoCDat criteria was high (average score 3.4 out of 4) as was the structural and organizational performance -- comparable to ICU registries in high-income countries. Identified strengths were types of variables included, reliability of coding, data completeness and validation. Potential improvements included extension of national coverage,optimization of recruitment completeness validation in all centers and the use of interobserver reliability checks. Conclusions: The Critical Care Asia platform evaluates well using standardised frameworks for data quality and equally to registries in resource-rich settings.