NCT03584399: ProsPICS

Prospective Evaluation of the Incidence of PICS

Terminated Last updated 25 April 2023

What this trial tests

trial testing PICS in critically ill pediatric population in Metabolism and Nutrition Disorder in 1 participant. Terminated before completion.

Timeline

1 March 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Indiana University
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	1
Start date	1 March 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• PICS in critically ill pediatric population

Conditions studied

• Metabolism and Nutrition Disorder — all drugs for Metabolism and Nutrition Disorder →

Sponsor

Indiana University

Who can join

Under 18, any sex, with Metabolism and Nutrition Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.