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Modulation of Molecular Fingerprinting in Pediatric Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055105
Recruitment Status : Unknown
Verified June 2015 by Phoenix Children's Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Phoenix Children's Hospital

Brief Summary:
The goal of this study is to demonstrate the sensitivity and specificity of detecting circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow expression and modulation of levels in response to therapy in comparison to current biomarkers.

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Procedure: miRNA in Sepsis Not Applicable

Detailed Description:
This study will aid in the evaluation of determining the accuracy of these miRNAs in pediatric patients and help in establishing pilot data for additional studies in the future. The testing will include blood samples, urine samples and buccal swabs from patients who meet eligibility at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including updated Pediatric Risk of Mortality (PRISM III) scores and simplified Therapeutic Intervention Scoring System(TISS-28) scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry. Data will be recorded in a de-identified manner on a Microsoft Excel database on a secure institutional server by the institutional staff. Data will then be analyzed to determine correlation of biomarkers to morbidity and mortality for these patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Modulation of Molecular Fingerprinting in Pediatric Sepsis
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
miRNA Procedure: miRNA in Sepsis
miRNA in Sepsis




Primary Outcome Measures :
  1. Risk of Mortality [ Time Frame: Duration of hospital stay, an expected average of 3 weeks ]
    Will compare PRISM 3 scores from baseline to hospital discharge.


Secondary Outcome Measures :
  1. Organ Failure [ Time Frame: Duration of hospital stay, an expected average of 3 weeks ]
    Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.

  2. Organ Dysfunction [ Time Frame: Duration of hospital stay, an expected average of 3 weeks ]
    Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization

  3. Patient acuity [ Time Frame: Duration of hospital stay, an expected average of 3 weeks ]
    Will assess TISS-28 scores throughout hospitalization.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1 through 18 years
  • Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital.
  • Patients must be enrolled int he study from arrival time tot he ED up to 24 hours from the time of initiation of antibiotic therapy for treatment of sepsis or septic shock.
  • Signed informed consent.

Exclusion Criteria:

  • Patients <1 year of age and greater than 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055105


Contacts
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Contact: Amit Misra, MD 6029331784 amisra@phoenixchildrens.com
Contact: Frederick A Willyerd, MD 6029331784 fwillyerd@phoenixchildrens.com

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85019
Contact: Amit Misra, MD    602-933-1784    amisra@phoenixchildrens.com   
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
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Principal Investigator: Frederick A Willyerd, MD Phoenix Children's Hospital

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Responsible Party: Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT02055105    
Other Study ID Numbers: PHNX-biosep-12159
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Keywords provided by Phoenix Children's Hospital:
Pediatric Sepsis
Additional relevant MeSH terms:
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Sepsis
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock