MedTrace Logo

Prospective Evaluation of the Incidence of PICS

NCT03584399 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Metabolism and Nutrition Disorder

Interventions

OTHER

PICS in critically ill pediatric population

Collection of additional blood sample from those subjects meeting criteria for the study.

Sponsors & Collaborators

  • American Society for Parenteral and Enteral Nutrition

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Courtney M Rowan, MD · Indiana University School of Medicine

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584399 on ClinicalTrials.gov