Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis (NCT05930418) | Clinical Trial Compass
CompletedNot Applicable
Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis
United States7 participantsStarted 2023-05-20
Plain-language summary
The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction.
Primary Objectives:
(Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer.
CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness.
(Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer
Who can participate
Age range
9 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between 9 and 25 years of age at time of study enrollment
* Currently receiving care for cancer at St. Jude
* Diagnosed with sepsis according to Phoenix score
Exclusion Criteria:
* Participant has been diagnosed with clinically significant left ventricular dysfunction (EF \< 55%) prior to the onset of sepsis
* Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
* Participant is pregnant
* Estimated glomerular filtration rate \< 45 ml/minute/1.73m2
* Does not meet MRI safety screening criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already completed recruitment and was focused on feasibility — meaning it was testing whether cardiac MRI could even be done in sick children with cancer and sepsis — has the data been published yet, and could you help me understand what the results might mean for my child's care?
2This study was specifically looking at pediatric oncology patients who develop sepsis, so could you explain whether my child's particular cancer diagnosis and current condition would have fit the profile of patients studied here, and how relevant the findings might be to our situation?
3The trial was measuring how often children in this situation develop something called 'subacute sepsis-associated cardiac disease' — can you explain what that condition means, how serious it is, and whether my child should be monitored for it regardless of this trial?
4Since this was a feasibility study rather than a treatment trial, it wasn't testing a new therapy — so can you help me understand what standard-of-care monitoring and treatment options exist right now for a child with cancer who develops sepsis or cardiovascular complications?
5Given that this study used cardiac MRI as a tool for identifying heart problems in this patient group, is cardiac MRI something you would recommend considering for my child, and are there any practical or safety barriers to getting one done given their current condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of cardiac MRI in pediatric oncology patients with sepsis
Timeframe: within 10 days after onset of sepsis
2
Frequency of subacute sepsis-associated cardiac disease