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4 results on '"Dalziel, Stuart R."'

1. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial

Author

Weiss, Scott L, Balamuth, Fran, Long, Elliot, Thompson, Graham C, Hayes, Katie L, Katcoff, Hannah, Cook, Marlena, Tsemberis, Elena, Hickey, Christopher P, Williams, Amanda, Williamson-Urquhart, Sarah, Borland, Meredith L, Dalziel, Stuart R, Gelbart, Ben, Freedman, Stephen B, Babl, Franz E, Huang, Jing, and Kuppermann, Nathan

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Kidney Disease, Pediatric, Infectious Diseases, Sepsis, Hematology, Patient Safety, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Renal and urogenital, Child, Crystalloid Solutions, Fluid Therapy, Humans, Randomized Controlled Trials as Topic, Saline Solution, Shock, Septic, Septic shock, Intravenous fluid, Crystalloid, Saline, Renal failure, Pragmatic trial, Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, General & Internal Medicine, Clinical sciences, Epidemiology, Health services and systems
Abstract

Background/aimsDespite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock.MethodsThe Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to

Published
2021

2. Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Research Networks (PERN) study

Author

Craig, Simon, Babl, Franz E, Dalziel, Stuart R, Gray, Charmaine, Powell, Colin, Al Ansari, Khalid, Lyttle, Mark D, Roland, Damian, Benito, Javier, Velasco, Roberto, Hoeffe, Julia, Moldovan, Diana, Thompson, Graham, Schuh, Suzanne, Zorc, Joseph J, Kwok, Maria, Mahajan, Prashant, Johnson, Michael D, Sapien, Robert, Khanna, Kajal, Rino, Pedro, Prego, Javier, Yock, Adriana, Fernandes, Ricardo M, Santhanam, Indumathy, Cheema, Baljit, Ong, Gene, Chong, Shu-Ling, and Graudins, Andis

Subjects
Lung, Pediatric, Asthma, Clinical Research, Clinical Trials and Supportive Activities, Emergency Care, Management of diseases and conditions, 7.3 Management and decision making, Respiratory, Acute Disease, Age Factors, Consensus, Delphi Technique, Endpoint Determination, Humans, Interviews as Topic, Outcome and Process Assessment, Health Care, Qualitative Research, Randomized Controlled Trials as Topic, Research Design, Risk Assessment, Risk Factors, Severity of Illness Index, Stakeholder Participation, Systematic Reviews as Topic, Treatment Outcome, Pediatric Emergency Research Networks, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine
Abstract

BACKGROUND:Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. METHODS/DESIGN:A 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of asthma severity. We will then identify practice differences in tne clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in acute paediatric asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with acute severe asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients/families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. DISCUSSION:The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

Published
2020

4. Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

Author

Lyttle, Mark D, Gamble, Carrol, Messahel, Shrouk, Hickey, Helen, Iyer, Anand, Woolfall, Kerry, Humphreys, Amy, Bacon, Naomi EA, Roper, Louise, Babl, Franz E, Dalziel, Stuart R, Ryan, Mary, Appleton, Richard E, and Kingdom, Emergency Res United

Subjects
lcsh:R5-920, Levetiracetam, Paediatric, Phenytoin, lcsh:Medicine (General), Status epilepticus, Seizure, Randomised
Abstract

Background Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE. Methods/design This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20 mg/kg, maximum 2 g) or levetiracetam (40 mg/kg, maximum 2.5 g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up. Discussion This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous second-line agent for CSE, and provide evidence for management recommendations. In addition, this trial will also provide data on which of these therapies is safer in this setting. Trial registration ISRCTN identifier, ISRCTN22567894 . Registered on 27 August 2015 EudraCT identifier, 2014-002188-13 . Registered on 21 May 2014 NIHR HTA Grant: 12/127/134

Published
2017

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