Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

NCT05930418 | Active Not Recruiting FDA Device

• 2 other identifiers: CRIMSON2NCI-2023-04528
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Respiratory Distress Syndrome; Sepsis; Cardiovascular Shock

Outcome Measures

Primary Outcomes (2)

• Feasibility of cardiac MRI in pediatric oncology patients with sepsis

  The proportion of enrolled participants who have evaluable cMRI data within 10 days after onset of sepsis

  within 10 days after onset of sepsis

• Frequency of subacute sepsis-associated cardiac disease

  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

  Within 10 days of presentation

Study Arms (1)

Cardiac MRI after sepsis

EXPERIMENTAL

Participants who meet the eligibility criteria of severe sepsis.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

Cardiac Magnetic Resonance provides more sensitive measure of ventricular volume and ejection fraction as well as novel markers of tissue characterization and edema assessment.

Cardiac MRI after sepsis

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Respiratory Distress Syndrome; Sepsis; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Shock

Study Officials

• Anthony Merlocco, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 5, 2023
• Study Start: May 20, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)