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Early Resuscitation in Paediatric Sepsis Using Inotropes - A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): Study Protocol and Analysis Plan.

ABSTRACT: Introduction: Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. We hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, we describe the protocol of the Early Resuscitation in Paediatric Sepsis Using Inotropes - A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED). Methods and analysis: The RESPOND ED study is an open label randomised controlled, two arm, multicentre pilot study conducted at four specialised paediatric Emergency Departments. Forty children aged between 28 days and 18 years treated for presumed septic shock will be randomized in a 1:1 ratio to early inotropes vs. standard fluid resuscitation. Early inotrope treatment is defined as the commencement of a continuous intravenous adrenaline infusion after 20 mL/kg fluid bolus resuscitation. Standard fluid resuscitation is defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to commencement of inotropes. In addition to feasibility outcomes, survival free of organ dysfunction censored at 28 days will be assessed as the main clinical outcome. The study cohort will be followed up at 28 days, and at 6 months post enrolment to assess quality of life and functional status. Biobanking nested in the study cohort will be performed to enable ancillary biomarker studies. Ethics and dissemination: The trial has ethical clearance (Children's Health Queensland, Brisbane, HREC/18/QCHQ/49168) and is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619000828123). Enrolment commenced on July 21st, 2019. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619000828123.

SUBMITTER: Harley A

PROVIDER: S-EPMC8200662 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Introduction: Septic shock remains amongst the leading causes of childhood mortality. Therapeutic options to support children with septic shock refractory to initial resuscitation with fluids and inotropes are limited. Recently, the combination of intravenous hydrocortisone with high dose ascorbic acid and thiamine (HAT therapy), postulated to reduce sepsis-related organ dysfunction, has been proposed as a safe approach with potential for mortality benefit, but randomized trials in paediatric patients are lacking. We hypothesize that protocolised early use of HAT therapy ("metabolic resuscitation") in children with septic shock is feasible and will lead to earlier resolution of organ dysfunction. Here, we describe the protocol of the Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation-A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU). Methods and Analysis: The RESPOND PICU study is an open label randomized-controlled, two-sided multicentre pilot study conducted in paediatric intensive care units (PICUs) in Australia and New Zealand. Sixty children aged between 28 days and 18 years treated with inotropes for presumed septic shock will be randomized in a 1:1 ratio to either metabolic resuscitation (1 mg/kg hydrocortisone q6h, 30 mg/kg ascorbic acid q6h, 4 mg/kg thiamine q12h) or standard septic shock management. Main outcomes include feasibility of the study protocol and survival free of organ dysfunction censored at 28 days. The study cohort will be followed up at 28-days and 6-months post enrolment to assess neurodevelopment, quality of life and functional status. Biobanking will allow ancillary studies on sepsis biomarkers. Ethics and Dissemination: The study received ethical clearance from Children's Health Queensland Human Research Ethics Committee (HREC/18/QCHQ/49168) and commenced enrolment on June 12th, 2019. The primary study findings will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12619000829112). Protocol Version: V1.8 22/7/20.

Project description:ImportanceSuicide is a leading cause of deaths in the United States. Although the emergency department (ED) is an opportune setting for initiating suicide prevention efforts, ED-initiated suicide prevention interventions remain underdeveloped.ObjectiveTo determine whether an ED-initiated intervention reduces subsequent suicidal behavior.Design, setting, and participantsThis multicenter study of 8 EDs in the United States enrolled adults with a recent suicide attempt or ideation and was composed of 3 sequential phases: (1) a treatment as usual (TAU) phase from August 2010 to December 2011, (2) a universal screening (screening) phase from September 2011 to December 2012, and (3) a universal screening plus intervention (intervention) phase from July 2012 to November 2013.InterventionsScreening consisted of universal suicide risk screening. The intervention phase consisted of universal screening plus an intervention, which included secondary suicide risk screening by the ED physician, discharge resources, and post-ED telephone calls focused on reducing suicide risk.Main outcomes and measuresThe primary outcome was suicide attempts (nonfatal and fatal) over the 52-week follow-up period. The proportion and total number of attempts were analyzed.ResultsA total of 1376 participants were recruited, including 769 females (55.9%) with a median (interquartile range) age of 37 (26-47) years. A total of 288 participants (20.9%) made at least 1 suicide attempt, and there were 548 total suicide attempts among participants. There were no significant differences in risk reduction between the TAU and screening phases (23% vs 22%, respectively). However, compared with the TAU phase, patients in the intervention phase showed a 5% absolute reduction in suicide attempt risk (23% vs 18%), with a relative risk reduction of 20%. Participants in the intervention phase had 30% fewer total suicide attempts than participants in the TAU phase. Negative binomial regression analysis indicated that the participants in the intervention phase had significantly fewer total suicide attempts than participants in the TAU phase (incidence rate ratio, 0.72; 95% CI, 0.52-1.00; P = .05) but no differences between the TAU and screening phases (incidence rate ratio, 1.00; 95% CI, 0.71-1.41; P = .99).Conclusions and relevanceAmong at-risk patients in the ED, a combination of brief interventions administered both during and after the ED visit decreased post-ED suicidal behavior.

Project description:PURPOSE:Sepsis is a common acute life-threatening condition that emergency physicians routinely face. Diagnostic options within the Emergency Department (ED) are limited due to lack of infrastructure, consequently limiting the use of invasive hemodynamic monitoring or imaging tests. The mortality rate due to sepsis can be assessed via multiple scoring systems, for example, mortality in emergency department sepsis (MEDS) score and sepsis patient evaluation in the emergency department (SPEED) score, both of which quantify the variation of mortality rates according to clinical findings, laboratory data, or therapeutic interventions. This study aims to improve the management processes of sepsis patients by comparing SPEED score and MEDS score for predicting the 28-day mortality in cases of emergency sepsis. METHODS:The study is a cross-sectional, prospective study including 61 sepsis patients in ED in Suez Canal University Hospital, Egypt, from August 2017 to June 2018. Patients were selected by two steps: (1) suspected septic patients presenting with at least one of the following abnormal clinical findings: (a) body temperature higher than 38 °C or lower than 36 °C, (b) heart rate higher than 90 beats/min, (c) hyperventilation evidenced by respiratory rate higher than 20 breaths/min or PaCO2 lower than 32 mmHg, and (d) white blood cell count higher than 12,000/?L or lower than 4000/?L; (2) confirmed septic patients with at least a 2-point increase from the baseline total sequential organ failure assessment (SOFA) score following infection. Other inclusion criteria included adult patients with an age ?18 years regardless of gender and those who had either systemic inflammatory response syndrome or suspected/confirmed infection. Patients were shortly follow-up for the 28-day mortality. Each patient was subject to SPEED score and MEDS score and then the results were compared to detect which of them was more effective in predicting outcome. The receiver operating characteristic curves were also done for MEDS and SPEED scores. RESULTS:Among the 61 patients, 41 died with the mortality rate of 67.2%. The mortality rate increased with a higher SPEED and MEDS scores. Both SPEED and MEDS scores revealed significant difference between the survivors and nonsurvivors (p = 0.004 and p < 0.001, respectively), indicating that both the two systems are effective in predicting the 28-day mortality of sepsis patients. Thereafter, the receiver operating characteristic curves were plotted, which showed that SPEED was better than the MEDS score when applied to the complete study population with an area under the curve being 0.87 (0.788-0.963) as compared with 0.75 (0.634-0.876) for MEDS. Logistic regression analysis revealed that the best fitting predictor of 28-day mortality for sepsis patients was the SPEED scoring system. For every one unit increase in SPEED score, the odds of 28-day mortality increased by 37%. CONCLUSION:SPEED score is more useful and accurate than MEDS score in predicting the 28-day mortality among sepsis patients. Therefore SPEED rather than MEDS should be more widely used in the ED for sepsis patients.

Project description:BackgroundSeveral health care systems internationally have implemented protocolised sepsis recognition and treatment bundles for children to improve outcomes, as recommended by the Surviving Sepsis Campaign. Successful implementation of clinical pathways is challenging and dependent on nurse engagement. There is limited data on knowledge translation during implementation of sepsis quality improvement programs.MethodsThis cross-sectional, multicentre observational survey study evaluated knowledge and perceptions of Emergency Department nurses in relation to the recognition, escalation and management of paediatric sepsis following implementation of a sepsis pathway. The study was conducted between September 2019 and March 2020 across 14 Emergency Departments in Queensland, Australia. The primary outcome was a sepsis knowledge score. An exploratory factor analysis was conducted to identify factors impacting nurses' perceptions of recognition, escalation and management of paediatric sepsis and their association with knowledge. Using a logistic mixed effects model we explored associations between knowledge, identified factors and other clinical, demographic and hospital site variables.ResultsIn total, 676 nurses responded to the survey and 534 were included in the analysis. The median knowledge score was 57.1% (IQR = 46.7-66.7), with considerable variation observed between sites. The exploratory factor analysis identified five factors contributing to paediatric sepsis recognition, escalation and management, categorised as 1) knowledge and beliefs, 2) social influences, 3) beliefs about capability and skills delivering treatment, 4) beliefs about capability and behaviour and 5) environmental context. Nurses reported strong agreement with statements measuring four of the five factors, responding lowest to the factor pertaining to capability and skills delivering treatment for paediatric sepsis. The factors knowledge and beliefs, capability and skills, and environmental context were positively associated with a higher knowledge score. Years of paediatric experience and dedicated nurse funding for the sepsis quality improvement initiative were also associated with a higher knowledge score.ConclusionTranslation of evidence to practice such as successful implementation of a sepsis care bundle, relies on effective education of staff and sustained uptake of protocols in daily practice. Our survey findings identify key elements associated with enhanced knowledge including dedicated funding for hospitals to target paediatric sepsis quality improvement projects.

Project description:Recent health policy changes have focused efforts on reducing emergency department (ED) visits as a way to reduce costs and improve quality of care. This was a systematic review of interventions based outside the ED aimed at reducing ED use.This study was designed as a systematic review. We reviewed the literature on interventions in five categories: patient education, creation of additional non-ED capacity, managed care, prehospital diversion, and patient financial incentives. Studies written in English, with interventions administered outside of the ED, and a comparison group where ED use was an outcome, were included. Two independent reviewers screened search results using MEDLINE, Cochrane, OAIster, or Scopus. The following data were abstracted from included studies: type of intervention, study design, population, details of intervention, effect on ED use, effect on non-ED health care use, and other health and financial outcomes. Quality of individual articles was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guidelines.Of 39 included studies, 34 were observational and five were randomized controlled trials. Two of five studies on patient education found reductions in ED use ranging from 21% to 80%. Out of 10 studies of additional non-ED capacity, four showed decreases of 9% to 54%, and one a 21% increase. Both studies on prehospital diversion found reductions of 3% to 7%. Of 12 studies on managed care, 10 had decreases ranging from 1% to 46%. Nine out of 10 studies on patient financial incentives found decreases of 3% to 50%, and one a 34% increase. Nineteen studies reported effect on non-ED use with mixed results. Seventeen studies included data on health outcomes, but 13 of these only included data on hospitalizations rather than morbidity and mortality. Seven studies included data on cost outcomes. According to the GRADE guidelines, all studies had at least some risk of bias, with four moderate quality, one low quality, and 34 very low quality studies.Many studies have explored interventions based outside the ED to reduce ED use in various populations, with mixed evidence. Approximately two-thirds identified here showed reductions in ED use. The interventions with the greatest number of studies showing reductions in ED use include patient financial incentives and managed care, while the greatest magnitude of reductions were found in patient education. These findings have implications for insurers and policymakers seeking to reduce ED use.

Project description:BackgroundFew studies have evaluated paediatric dermatological conditions and their associated factors that warrant admission at the emergency department.ObjectivesThe main objective of this study was to present the demographic information of paediatric dermatological conditions encountered in the emergency department and identify possible associated factors for hospital admission.MethodsThis retrospective cross-sectional study included paediatric patients who visited the emergency department between 1 January 2016 and 31 December 2019. Data collection was performed using an authorised electronic medical records programme at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand.ResultsA total of 40 683 paediatric patients visited the emergency department during the study period, with 1701 cases presenting dermatological conditions. Infections were the most frequent conditions encountered in the emergency department (647, 38.0%), followed by urticaria/anaphylaxis (478, 28.1%), eczematous diseases (463, 27.2%), cutaneous drug eruptions (64, 3.7%) and miscellaneous (49, 2.9%). Among 1701 paediatric cases with dermatological conditions, only 182 cases (10.7%) were admitted to the hospital and required further management. Cases presenting cutaneous drug eruptions had the highest proportion of hospital admissions (60.9%) and were significantly different from cases in other dermatologic categories (p<0.001). The association of admission found an OR of 0.96 for every year of increase in age (95% CI 0.93 to 0.99, p=0.003).ConclusionThe present study found that the majority of patients with cutaneous conditions visiting the emergency department were non-urgent; however, dermatological emergencies exist and should not be underestimated. Younger paediatric patients presenting with dermatological condition is a population with a high risk for hospital admission. Cutaneous drug eruptions showed the highest proportion of hospital admissions compared with other dermatological categories. Therefore, physicians in the emergency department should always look for specific cutaneous signs of drug eruptions, such as target-like lesions and mucosal involvement in Steven-Johnsons syndrome/toxic epidermal necrolysis to prevent misdiagnosis of this dermatological condition.

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Early Resuscitation in Paediatric Sepsis Using Inotropes - A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): Study Protocol and Analysis Plan.

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