Outcomes of Children After Hospitalization in Intensive Care Unit

Sepsis Clinical Trial

— APCI  

Official title:

After Pediatric Critical Illness (APCI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06124092
• Other study ID #: CHUSJ MP-21-2023-5097
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: March 2029

Study information

• Verified date: November 2023
• Source: St. Justine's Hospital
• Contact: Geneviève Du Pont-Tibodeau, MD
• Phone: 514-345-4931
• Email: genevieve.du.pont-thibodeau.med[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p).

It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

Description:

The Pediatric Post-Intensive Care Syndrome (PICS-p) is a newly developed conceptual framework that incorporates the constellation of morbidities that are increasingly recognized to affect children and their families after a critical illness. Experts define PICS-p as a new or worsening impairment in any of the following 5 domains of child health: physical, cognitive, emotional, social, or family.

In contrast to well established follow-up programs in adults, there is currently a lack of systematic follow-up of PICU survivors which prevents both the recognition and management of PICS-p. The absence of granular, empirical data on the recovery of PICU children impedes both the identification and management of PICS-p.

This project is a prospective Canadian multicenter cohort study to identify risk factors of PICS-p, develop and validate a predictive model for PICS-p to detect at-risk children, characterize each domain of PICS-p over two years post critical illness and uncover additional morbidities that are not captured using the current PICS-p framework. This study will provide granular, empirical data on which to build developmentally appropriate and tailored screening, management, and intervention programs during and after PICU to improve the global recovery of critically ill children and their family.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 690
• Est. completion date: March 2029
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children =18yo hospitalized in PICU for =96 hours

Exclusion Criteria:

1. gestational age <37 weeks or age >18 years at PICU entry;

2. admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);

3. anticipated life expectancy <1year (e.g., active do not resuscitate status).

Related Conditions & MeSH terms

• Bronchiolitis
• Heart Diseases
• Liver Diseases
• Pneumonia
• Renal Disease
• Sepsis
• Septic Shock
• Trauma Injury

Intervention

Other:
• neurocognitive tests
Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	Montreal Children Hospital	Montréal	Quebec
Canada	Childrens Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children Hospital	Vancouver	British Colombia

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe families' healthcare requirements throughout their recovery process after PICU.	Descrie the variety of healthcare professional and medical required post PICU hospitalization.	Until 36 months post PICU discharge
Primary	Identify risk factors of PICS-p at 2 months post-PICU	Identification of modifiable and non-modifiable risk factors	2 months after PICU discharge
Primary	Develop and validate a model predictive of PICS-p 2 months post PICU	The model will allow detection at PICU discharge of children in need of post-PICU follow-up	2 months after PICU discharge
Secondary	Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU	Identify which domain gets impacted and when during the course of the follow-up	At 2 months, 12, 18 months and 36 months post PICU discharge
Secondary	Uncover additional post-PICU morbidities not detected within the framework of PICS-p.	Detection of morbidities through the medical provider interview that are not included in the current framework.	Until 36 months post PICU discharge