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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: Clinical Trial study, sponsored by Indiana University.
NCT03584399 is a clinical trial that was terminated before completion, run by Indiana University. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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).
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 |
Why NCT03584399 stopped before completion
NCT03584399 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which PICS in critically ill pediatric population is the first listed.
NCT03584399 does not publish any study locations in the registry export this page uses.
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.
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