Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06124092
Other study ID # CHUSJ MP-21-2023-5097
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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).

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
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
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3