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Prospective Evaluation of the Incidence of PICS (ProsPICS)

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ClinicalTrials.gov Identifier: NCT03584399
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
American Society for Parenteral and Enteral Nutrition
Information provided by (Responsible Party):
Courtney Rowan, Indiana University

Brief Summary:
Advances in modern medicine and critical care interventions have greatly impacted survival of critically ill patients, but these interventions are not without consequences. Although patients may now survive the initial critical illness, these patients may not recover to their pre-illness baseline state of health. Recent data in both the critically ill adult and neonatal patients who survive sepsis or surgical events have been shown to progress to persistent inflammatory, immunosuppressed, catabolic syndrome (PICS). This was first identified in adult trauma patients, and more recently was defined in critically ill neonates. To date, there are no published reports of PICS in the critically ill pediatric population. Our long-term goal is to understand PICS in the pediatric population and how early medical and nutritional interventions may impact overall morbidity and survival. To achieve this goal first PICS must first be characterized in the pediatric population. The hypothesis is that PICS occurs in pediatric patients and is associated with increased time to return to a baseline functional life post-injury or illness. The hypothesis will be tested by pursuing the following specific aims. Specific Aim 1: To determine the incidence of PICS in the pediatric population and associate the diagnosis of PICS to survival and time to return to baseline functional life and Specific Aim 2: To determine if early increased inflammatory and immunosuppressive markers are associated with the development of PICS and increased morbidity and mortality. These aims will be accomplished by conducting a prospective single-center observational pilot study to enroll pediatric patients with an anticipated pediatric intensive care unit (PICU) stay greater than 14 days. Through these two aims, the investigators anticipate that this research will provide an explanation into the interplay of inflammation, immunosuppression, and catabolism in critically ill children, which is imperative to the development of early therapeutic and nutritional interventions that can reduce morbidity and mortality associated with critical illness.

Condition or disease Intervention/treatment
Metabolism and Nutrition Disorder Other: PICS in critically ill pediatric population

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Incidence of Persistent Inflammatory, Immunosuppressed, Catabolic Syndrome in the Critically Ill Pediatric Population
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nutrition


Intervention Details:
  • Other: PICS in critically ill pediatric population
    Collection of additional blood sample from those subjects meeting criteria for the study.


Primary Outcome Measures :
  1. Occurrence of PICS in the pediatric critical care population [ Time Frame: July 1, 2018 to June 30, 2019 ]
    Diagnosis of PICS will be determined when a patient has been admitted to the PICU for >14 days and has signs of both inflammation (CRP >15mg/L) and immunosuppression (total lymphocyte count < 0.80×109/L), as well as catabolism (Serum albumin < 3.0g/dL, Prealbumin <10mg/dL, Retinol binding protein <10μg/dL, and weight loss >10% or body mass index <18 during hospitalization).


Secondary Outcome Measures :
  1. Mortality [ Time Frame: July 1, 2018 to June 30 2019 ]
    Death in the ICU associated with PICS


Biospecimen Retention:   Samples With DNA
In addition to CRP and TLC, which will be collected at 14 days (± 1 day) of PICU admission , an additional blood samples will be collected at these time points to be frozen for further analysis. At the time of blood collection, an additional 5 mL of blood will be collected, processed, and stored at -80 degree Celsius. Once desired time-points are identified and further funding obtained, samples will be processed in batches to evaluate biochemical markers of inflammation. This will be performed using The Inflammatory Cytokine Human Magnetic 5-Plex Panel for the Luminex™ platform. This will quantify GM-CSF, IL-1β, IL-6, IL-8 and TNF-α in serum samples.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be admitted the to pediatric intensive care unit of Riley Hospital for Children.
Criteria

Inclusion Criteria:

  • Patients who are < or = to 18 years of age and have an anticipated length of PICU stay of > or = to 14 days from June 1, 2018 through January 31, 2019

Exclusion Criteria:

  • Chronic mechanical ventilation, Known chronic inflammatory disease process, or Diagnosed with failure to thrive or malnutrition upon admission to the PICU

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): NCT03584399


Contacts
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Contact: Melisa L Bales 317-944-7065 melbales@iupui.edu
Contact: Jill Mazurczyk, MPH 317-944-3346 jmazurcz@iu.edu

Locations
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United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Courtney Rowan, MD         
Sponsors and Collaborators
Indiana University
American Society for Parenteral and Enteral Nutrition
Investigators
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Principal Investigator: Courtney M Rowan, MD Indiana University School of Medicine

Publications:
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Responsible Party: Courtney Rowan, Assistant Professor Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT03584399     History of Changes
Other Study ID Numbers: 1802247905
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be entered and stored in in a de-identified/HIPAA compliant manner using a password protected web-based database that has securities to protect confidentiality and data integrity. The database will be constructed in REDCap.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nutrition Disorders