RECRUITING

Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Cardiovascular Magnetic Resonance Prognosticators In Pediatric Oncology Patients With Sepsis: A Priority Pilot Study

Quick Facts

Study Start:2023-05-20
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05930418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 9 and 25 years of age at time of study enrollment
  2. * Currently receiving care for cancer at St. Jude
  3. * Diagnosed with severe sepsis according to consensus criteria
  1. * History of allogeneic hematopoietic cell transplantation or CAR-T cell therapy
  2. * Participant has been diagnosed with clinically significant left ventricular dysfunction (EF \< 55%) prior to the onset of sepsis
  3. * 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.
  4. * Estimated glomerular filtration rate \< 45 ml/minute/1.73m2
  5. * Does not meet MRI safety screening criteria.

Contacts and Locations

Study Contact

Anthony Merlocco, MD
CONTACT
866-870-5570
amerlocc@uthsc.edu
Joshua Wolf, MBBS. PhD
CONTACT
866-870-5570
joshua.wolf@stjude.org

Principal Investigator

Anthony Merlocco, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Anthony Merlocco, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

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

Study Start Date2023-05-20
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-05-20
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Respiratory Distress Syndrome
  • Sepsis
  • Cardiovascular Shock