Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

The primary purpose of this study is to evaluate the feasibility of obtaining cardiac MRI in pediatric patients with cancer post-septic shock which will be completed in an initial 5 patients to establish feasibility of successfully completing first study CMR within ten days of sepsis presentation without sedation.
This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for analysis of cardiovascular abnormalities and recovery in sepsis.
Feasibility Phase
The feasibility phase of the study will comprise the first 5 study participants. The aim of this stage is to establish feasibility of successfully completing the initial study CMR within ten days of sepsis presentation without sedation.
At completion of the feasibility phase, (first 5 participants) feasibility of data collection will be evaluated using the following stopping rule: If at least 4 of attempted 5 patient scans provide adequate available data for CMR analysis and can be completed without sedation or delay beyond the 10-day window (due to coordination or deferral due to hemodynamic instability), the study may continue to the completion phase. If fewer than 4 participants are able to complete the cardiac MRI, the study will be paused until any factors that can improve the feasibility may be identified. Data obtained during the feasibility phase will be included in analysis of CMR abnormalities.
Completion Phase
The Completion Phase will comprise approximately 20 participants in order to complete the pilot study to evaluate for abnormalities on CMR.
We estimate the feasibility phase will require up to 6 months to accrue and perform first CMR for the initial 5 patients and the completion phase will require an additional up to 18 months to accrue 15 additional patients who can complete CMR evaluation

Source: View full study details on ClinicalTrials.gov

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July 8, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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