Browsing by Author "Choong, Karen"

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    Erratum to: Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial
    (2017-08-18) Duffett, Mark; Choong, Karen; Foster, Jennifer; Gilfoyle, Elaine; Lacroix, Jacques; Pai, Nikhil; Thabane, Lehana; Cook, Deborah J
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    Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial
    (2017-05-19) Duffett, Mark; Choong, Karen; Foster, Jennifer; Gilfoyle, Elaine; Lacroix, Jacques; Pai, Nikhil; Thabane, Lehana; Cook, Deborah J
    Abstract Background Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences—increasing the risk of nosocomial infections—which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo. Methods A multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve: 1. Effective screening: If >80% of eligible patients are approached for consent. 2. Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible. 3. Participant accrual: If the average monthly enrolment is two or more participants per centre per month. 4. Protocol adherence: if >90% of doses are administered according to the protocol. Discussion There are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use—where clinicians prescribe prophylaxis to the more severely ill—a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential. Trial registration ClinicalTrials.gov: NCT02929563 (Registered October 3, 2016).
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    Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial
    (2024-09-19) O’Hearn, Katie; Menon, Kusum; Albrecht, Lisa; Amrein, Karin; Britz-McKibbin, Philip; Cayouette, Florence; Choong, Karen; Foster, Jennifer R.; Fergusson, Dean A.; Floh, Alejandro; Fontela, Patricia; Geier, Pavel; Gilfoyle, Elaine; Guerra, Gonzalo G.; Gunz, Anna; Helmeczi, Erick; Khamessan, Ali; Joffe, Ari R.; Lee, Laurie; McIntyre, Lauralyn; Murthy, Srinivas; Parsons, Simon J.; Ramsay, Tim; Ryerson, Lindsay; Tucci, Marisa; McNally, Dayre
    Abstract Background The rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group’s phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children. Methods Our aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained. Discussion The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026. Trial registration Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505