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Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

Primary Purpose

Acute Respiratory Distress Syndrome, Sepsis, Cardiovascular Shock

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac MRI
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

9 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Jude Children's Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac MRI after sepsis

Arm Description

Participants who meet the eligibility criteria of severe sepsis.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2023
Last Updated
August 25, 2023
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05930418
Brief Title
Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis
Official Title
Cardiovascular Magnetic Resonance Prognosticators In Pediatric Oncology Patients With Sepsis: A Priority Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Sepsis, Cardiovascular Shock

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac MRI after sepsis
Arm Type
Experimental
Arm Description
Participants who meet the eligibility criteria of severe sepsis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac MRI
Intervention Description
Cardiac Magnetic Resonance provides more sensitive measure of ventricular volume and ejection fraction as well as novel markers of tissue characterization and edema assessment.
Primary Outcome Measure Information:
Title
Feasibility of cardiac MRI in pediatric oncology patients with sepsis
Description
The proportion of enrolled participants who have evaluable cMRI data within 10 days after onset of sepsis
Time Frame
within 10 days after onset of sepsis
Title
Frequency of subacute sepsis-associated cardiac disease
Description
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
Time Frame
Within 10 days of presentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Merlocco, MD
Phone
866-870-5570
Email
amerlocc@uthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Wolf, MBBS. PhD
Phone
866-870-5570
Email
joshua.wolf@stjude.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Merlocco, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Merlocco, MD
Phone
866-278-5833
Email
referralinfo@stjude.org

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

Learn more about this trial

Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

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