Other Clinical Trial - Post-Intensive Care Syndrome

Status Recruiting

Clinical Trial Summary

Pediatric Intensive Care Unit (PICU) survival has increased substantially over the past three decades. Currently, an understanding of PICU morbidity and recovery among PICU survivors and their families is limited. Post-intensive care syndrome (PICS) consists of new or worsening impairments in physical, cognitive, or mental health status that arise and may persist after critical illness. The characteristics of PICS in children (PICS-p) are unknown. The objective of this study is to learn about pediatric recovery from critical illness to guide future intervention research to optimize child and family health.

Clinical Trial Description

PICS-p is a prospective longitudinal cohort study of pediatric patients experiencing 3 or more days of intensive care therapies at one of approximately 30 U.S. PICUs to evaluate child and family outcomes over two years post-PICU discharge. We will compare outcomes of these PICU patients with a control group of patients who received an overnight PICU stay but did not receive intensive care therapies, as well as with published quality of life data from the general and chronically ill populations. Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff, and their post-discharge outcomes will be followed centrally from the University of Pennsylvania and the Seattle Children's Research Institute. Our specific aims are to determine the physical, cognitive, emotional, and social health outcomes and trajectory of recovery in a population of children post-critical illness; to determine the baseline health, presenting problem, and PICU factors associated with impaired physical, cognitive, emotional, and social outcomes among PICU survivors; and to determine the emotional and social health outcomes in parents and siblings of PICU survivors. Our primary goal is to explicate the impact of pediatric critical illness over a two-year period of time to guide future intervention research to optimize child and family outcomes. Our overall goal is to improve the health and well-being of PICU survivors and their families. ;

Study Design

Related Conditions & MeSH terms

Critical Illness
Post Intensive Care Unit Syndrome
Syndrome

Clinical Trial Details

NCT number	NCT04967365
Study type	Observational
Source	University of Pennsylvania
Contact	Martha AQ Curley, RN, PhD
Phone	215-573-9449
Email	curley@upenn.edu
Status	Recruiting
Phase
Start date	July 27, 2021
Completion date	June 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04551508` - Delirium Screening 3 Methods Study
Recruiting	`NCT06037928` - Plasma Sodium and Sodium Administration in the ICU
Completed	`NCT03671447` - Enhanced Recovery After Intensive Care (ERIC)	N/A
Recruiting	`NCT03941002` - Continuous Evaluation of Diaphragm Function	N/A
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed	`NCT04239209` - Effect of Intensivist Communication on Surrogate Prognosis Interpretation	N/A
Completed	`NCT05531305` - Longitudinal Changes in Muscle Mass After Intensive Care	N/A
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Completed	`NCT02916004` - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.	N/A
Recruiting	`NCT05883137` - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed	`NCT04479254` - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)	N/A
Recruiting	`NCT04475666` - Replacing Protein Via Enteral Nutrition in Critically Ill Patients	N/A
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Withdrawn	`NCT04043091` - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction	N/A
Recruiting	`NCT02922998` - CD64 and Antibiotics in Human Sepsis	N/A
Recruiting	`NCT02989051` - Fluid Restriction Keeps Children Dry	Phase 2/Phase 3
Completed	`NCT02899208` - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?	N/A
Completed	`NCT03048487` - Protein Consumption in Critically Ill Patients
Recruiting	`NCT02163109` - Oxygen Consumption in Critical Illness

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study — PICS-p

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms