Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03584399 · ClinicalTrials.gov registry record
Prospective Evaluation of the Incidence of PICS
A clinical trial, sponsored by Indiana University.
- Terminated
- Registry status
- 1
- Enrollment target
NCT03584399 is a clinical trial that was terminated before completion, run by Indiana University. The registered enrollment target is 1 participants.
The verdict
NCT03584399 was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
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 deve
Interventions
- OTHER PICS in critically ill pediatric population
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2020-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03584399
The ClinicalTrials.gov registry entry for NCT03584399 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PICS in critically ill pediatric population is the first listed.
NCT03584399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03584399 about?
NCT03584399 is a clinical study titled "Prospective Evaluation of the Incidence of PICS". 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 st...
What is the current status of trial NCT03584399?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2019-03-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03584399?
The interventions under investigation include: PICS in critically ill pediatric population (OTHER).
Who is sponsoring clinical trial NCT03584399?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.