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Objectives To develop evidence-based recommendations for clinicians caring for children (including infants, school-aged children, and adolescents) with septic shock and other sepsis-associated organ dysfunction. Design A panel of 49 international experts, representing 12 international organizations, as well as three methodologists and three public members was convened. Panel members assembled at key international meetings (for those panel members attending the conference), and a stand-alone meeting was held for all panel members in November 2018. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. Teleconferences and electronic-based discussion among the chairs, co-chairs, methodologists, and group heads, as well as within subgroups, served as an integral part of the guideline development process. Methods The panel consisted of six subgroups: recognition and management of infection, hemodynamics and resuscitation, ventilation, endocrine and metabolic therapies, adjunctive therapies, and research priorities. We conducted a systematic review for each Population, Intervention, Control, and Outcomes question to identify the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak, or as a best practice statement. In addition, 'in our practice' statements were included when evidence was inconclusive to issue a recommendation, but the panel felt that some guidance based on practice patterns may be appropriate. Results The panel provided 77 statements on the management and resuscitation of children with septic shock and other sepsis-associated organ dysfunction. Overall, six were strong recommendations, 49 were weak recommendations, and nine were best-practice statements. For 13 questions, no recommendations could be made; but, for 10 of these, 'in our practice' statements were provided. In addition, 52 research priorities were identified. Conclusions A large cohort of international experts was able to achieve consensus regarding many recommendations for the best care of children with sepsis, acknowledging that most aspects of care had relatively low quality of evidence resulting in the frequent issuance of weak recommendations. Despite this challenge, these recommendations regarding the management of children with septic shock and other sepsis-associated organ dysfunction provide a foundation for consistent care to improve outcomes and inform future research., Author(s): Scott L. Weiss [sup.1], Mark J. Peters [sup.2], Waleed Alhazzani [sup.3] [sup.4], Michael S. D. Agus [sup.5], Heidi R. Flori [sup.6], David P. Inwald [sup.7], Simon Nadel [sup.7], Luregn [...]

Author(s): Scott L. Weiss [sup.1], Mark J. Peters [sup.2], Waleed Alhazzani [sup.3], Michael S. D. Agus [sup.4] [sup.5], Heidi R. Flori [sup.6], David P. Inwald [sup.7], Simon Nadel [sup.7], Luregn [...]

Background Oxygen saturation monitoring for children receiving respiratory support is standard worldwide. No randomised clinical trials have compared peripheral oxygen saturation (SpO.sub.2) targets for critically ill children. The harm of interventions to raise SpO.sub.2 to > 94% may exceed their benefits. Methods We undertook an open, parallel-group randomised trial of children > 38 weeks completed gestation and 94%) or a conservative oxygenation group (SpO.sub.2 = 88-92% inclusive). Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between-group separation of SpO.sub.2 and safety. The Oxy-PICU trial was registered before recruitment: ClinicalTrials.gov identifier NCT03040570. Results A total of 159 children met the inclusion criteria, of whom 119 (75%) were randomised between April and July 2017, representing a rate of 10 patients per month per site. The mean time to randomisation from first contact with an intensive care team was 1.9 (SD 2.2) h. Consent to continue in the study was obtained in 107 cases (90%); the children's parents/legal representatives were supportive of the consent process. The median (interquartile range, IQR) of time-weighted individual mean SpO.sub.2 was 94.9% (92.6-97.1) in the conservative oxygenation group and 97.5% (96.2-98.4) in the liberal group [difference 2.7%, 95% confidence interval (95% CI) 1.3-4.0%, p < 0.001]. Median (IQR) time-weighted individual mean FiO.sub.2 was 0.28 (0.24-0.37) in the conservative group and 0.37 (0.30-0.42) in the liberal group (difference 0.08, 95% CI 0.03-0.13, p < 0.001). There were no significant between-group differences in length of stay, duration of organ support or mortality. Two prespecified serious adverse events (cardiac arrests) occurred, both in the liberal oxygenation group. Conclusion A definitive clinical trial of peripheral oxygen saturation targets is feasible in critically ill children., Author(s): Mark J. Peters [sup.1] [sup.2], Gareth A. L. Jones [sup.1] [sup.2], Daisy Wiley [sup.3], Jerome Wulff [sup.3], Padmanabhan Ramnarayan [sup.4] [sup.5], Samiran Ray [sup.2], David Inwald [sup.5], Michael Grocott [...]

Background Intensive Care Medicine set us the task of outlining a global clinical research agenda for paediatric intensive care (PIC). In line with the clinical focus of this journal, we have limited this to research that may directly influence patient care. Methods Clinician researchers from PIC research networks of varying degrees of formality from around the world were invited to answer two main questions: (1) What have been the major recent advances in paediatric critical care research? (2) What are the top 10 studies for the next 10 years? Results (1) Inclusive databases are well established in many countries. These registries allow detailed observational studies and feasibility testing of clinical trial protocols. Recent trials are larger and more valuable, and (2) most common interventions in PIC are not evidenced-based. Clinical studies for the next 10 years should address this deficit, including: ventilation techniques and interfaces; fluid, transfusion and feeding strategies; optimal targets for vital signs; multiple organ failure definitions, mechanisms and treatments; trauma, prevention and treatment; improving safety; comfort of the patient and their family; appropriate care in the face of medical complexity; defining post-PICU outcomes; and improving knowledge generation and adoption, with novel trial design and implementation strategies. The group specifically highlighted the need for research in resource-limited environments wherein mortality remains often tenfold higher than in well-resourced settings. Conclusion Paediatric intensive care research has never been healthier, but many gaps in knowledge remain. We need to close these urgently. The impact of new knowledge will be greatest in resource-limited environments., Author(s): Mark J. Peters [sup.1], Andrew Argent [sup.2], Marino Festa [sup.3], Stéphane Leteurtre [sup.4], Jefferson Piva [sup.5], Ann Thompson [sup.6], Douglas Willson [sup.7], Pierre Tissières [sup.8], Marisa Tucci [sup.9] [sup.10], [...]

Aims To determine whether the paediatric intensive care (PIC) population weight distribution differs from the UK reference population and whether weight-for-age at admission is an independent risk factor for mortality. Methods Admission weight-for-age standard deviation scores (SDS) were calculated for all PIC admissions (March 2003-December 2011) to Great Ormond Street Hospital: this is the number of standard deviations (SD) between a child's weight and the UK mean weight-for-age. Categorised into nine SDS groups, standardised mortality ratios (SMR) and logistic regression were used to assess the relationship between weight-for-age at admission and risk-adjusted mortality. Results Out of 12,458 admissions, mean weight-for-age was 1.04 SD below the UK reference population mean (p < 0.0001). Based on 942 deaths, risk-adjusted mortality was lowest in those with mild-to-moderately raised weight-for-age (SDS 0.5-2.5) and highest in children with extreme under- or overweight (SDS +3.5). Logistic regression indicated that age, gender, ethnicity and weight-for-age are independent risk factors for mortality. South Asian and 'other' ethnicities had significantly increased risk of death compared to children of white and black ethnic origin. Conclusion The PIC population mean weight-for-age is significantly lower than the UK reference mean. The extremes of weight-for-age are over-represented, especially underweight. Weight-for-age at admission is an independent risk factor for mortality. A U-shaped association between weight and risk-adjusted mortality exists, with the lowest risk of death in children who are mild-to-moderately overweight. Future studies should determine the impact of malnutrition on risk-adjusted mortality and investigate the aetiology of risk disparities with ethnicity., Author(s): Nicholas J. Prince [sup.1], Katherine L. Brown [sup.2], Teumzghi F. Mebrahtu [sup.3], Roger C. Parslow [sup.3], Mark J. Peters [sup.1] [sup.4] Author Affiliations: (1) grid.83440.3b, 0000000121901201, Respiratory Critical Care [...]

Background: Oxygen saturation monitoring for children receiving respiratory support is standard worldwide. No randomised clinical trials have compared peripheral oxygen saturation (SpO2) targets for critically ill children. The harm of interventions to raise SpO2 to > 94% may exceed their benefits.Methods: We undertook an open, parallel-group randomised trial of children > 38 weeks completed gestation and < 16 years of age receiving invasive or non-invasive respiratory support and supplemental oxygen who were admitted urgently to one of three paediatric intensive care units. A 'research without prior consent' approach was employed. Children were randomly assigned to a liberal oxygenation group (SpO2 targets > 94%) or a conservative oxygenation group (SpO2 = 88-92% inclusive). Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between-group separation of SpO2 and safety. The Oxy-PICU trial was registered before recruitment: ClinicalTrials.gov identifier NCT03040570.Results: A total of 159 children met the inclusion criteria, of whom 119 (75%) were randomised between April and July 2017, representing a rate of 10 patients per month per site. The mean time to randomisation from first contact with an intensive care team was 1.9 (SD 2.2) h. Consent to continue in the study was obtained in 107 cases (90%); the children's parents/legal representatives were supportive of the consent process. The median (interquartile range, IQR) of time-weighted individual mean SpO2 was 94.9% (92.6-97.1) in the conservative oxygenation group and 97.5% (96.2-98.4) in the liberal group [difference 2.7%, 95% confidence interval (95% CI) 1.3-4.0%, p < 0.001]. Median (IQR) time-weighted individual mean FiO2 was 0.28 (0.24-0.37) in the conservative group and 0.37 (0.30-0.42) in the liberal group (difference 0.08, 95% CI 0.03-0.13, p < 0.001). There were no significant between-group differences in length of stay, duration of organ support or mortality. Two prespecified serious adverse events (cardiac arrests) occurred, both in the liberal oxygenation group.Conclusion: A definitive clinical trial of peripheral oxygen saturation targets is feasible in critically ill children. [ABSTRACT FROM AUTHOR]