Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis
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
Conditions:
🦠 Acute Respiratory Distress Syndrome 🦠 Sepsis 🦠 Cardiovascular Shock
🗓️ Study Start (Actual) 20 May 2023
🗓️ Primary Completion (Estimated) 31 July 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Memphis, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Between 9 and 25 years of age at time of study enrollment
    • * Currently receiving care for cancer at St. Jude
    • * Diagnosed with severe sepsis according to consensus criteria

    Exclusion Criteria:

    • * History of allogeneic hematopoietic cell transplantation or CAR-T cell therapy
    • * 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.
Ages Eligible for Study: 9 Years to 25 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 June 2023
  • First Submitted that Met QC Criteria 24 June 2023
  • First Posted 5 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 February 2024
  • Last Update Posted 7 February 2024
  • Last Verified February 2024