Renal DiseaseAPCINCT06124092
Outcomes of Children After Hospitalization in Intensive Care Unit
An observational study of Renal Disease and Liver Diseases, run by St. Justine's Hospital at 8 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Renal Disease, Liver Diseases, Heart Diseases
- What is being tested?
- neurocognitive tests
- How many people
- 690 participants
- Where
- 8 sitesCanada
- Study dates
- Mar 2024to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient admitted to Pediatric Intensive Care Unit for 96 hours or more will be included in the study unless they age a gestionnal age <37 weeks or are over 18 years-old or were admitted to PICu for congenital heart surgery (as they are followed in neuro-cardiac clinic) and for whom the life expectancy is less than 1 year.
Who may be able to join
- Children ≤18yo hospitalized in PICU for ≥96 hours
Who cannot join
- gestational age <37 weeks or age >18 years at PICU entry;
- admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
- anticipated life expectancy <1year (e.g., active do not resuscitate status).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Geneviève Du Pont-Tibodeau, MD contact
Laurence Ducharme-Crevier, MD contact
8 sites in 1 country
Canada8 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Laurie Lee, MD, Laurie.Lee@albertahealthservices.ca
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Karen Choong, MD, choongk@mcmaster.ca
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Nadia Roumeliotis, MD, 514-345-4931 ext. 7177, nadezhda.roumeliotis.med@ssss.gouv.qc.ca
Montreal Children Hospital
Montreal, Quebec, H4A 3J1
Patricia Fontela, MD, patricia.fontela@mcgill.ca
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Dayre McNally, MD, dmcnally@cheo.on.ca
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1J 3H5
Jean-Sébastien Tremblay-Roy, MD, 819-346-1100 ext. 70188, jean-sebastien.tremblay-roy@usherbrooke.ca
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Nicole McKinnon, nicole.mckinnon@sickkids.ca
BC Children Hospital
Vancouver, British Colombia, V6H 3N1
Jenny Retallack, MD, jretallack@cw.bc.ca
About this study
Official title: After Pediatric Critical Illness (APCI)
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.
Read the detailed 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.
- Conditions
- Renal Disease, Liver Diseases, Heart Diseases, Trauma Injury, Sepsis, Septic Shock
- Being tested
- neurocognitive tests
- Keywords
- Pediatric Intensive Care Unit, PICU
- Medical subject headings
- Kidney Diseases, Liver Diseases, Heart Diseases, Accidental Injuries, Sepsis, Shock, Septic, Pneumonia, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitive testsOther
Also called Quality of life
Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify risk factors of PICS-p at 2 months post-PICU
Identification of modifiable and non-modifiable risk factors
Measured: 2 months after PICU discharge
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
Measured: 2 months after PICU discharge
Secondary outcomes (2)
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
Measured: At 2 months, 12, 18 months and 36 months post PICU discharge
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.
Measured: Until 36 months post PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Genevieve Du Pont-Thibodeau, St. Justine's Hospital
- Investigators
- Geneviève Du Pont-Thibodeau, MD, Principal investigator, St. Justine's HospitalLaurence Cucharme-Crevier, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124092
- Sponsor's protocol ID
- CHUSJ MP-21-2023-5097
- Acronym
- APCI
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Pediatric Critical Illness (APCI)
- ClinicalTrials.gov ID
- NCT06124092
- Acronym / sponsor ID
- APCI / CHUSJ MP-21-2023-5097
- Conditions
- Renal Disease, Liver Diseases, Heart Diseases, Trauma Injury, Sepsis, Septic Shock
- Keywords
- Pediatric Intensive Care Unit, PICU
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient admitted to Pediatric Intensive Care Unit for 96 hours or more will be included in the study unless they age a gestionnal age <37 weeks or are over 18 years-old or were admitted to PICu for congenital heart surgery (as they are followed in neuro-cardiac clinic) and for whom the life expectancy is less than 1 year.
Key inclusion criteria (1 listed)
- Children ≤18yo hospitalized in PICU for ≥96 hours
Key exclusion criteria (3 listed)
- gestational age <37 weeks or age >18 years at PICU entry;
- admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
- anticipated life expectancy <1year (e.g., active do not resuscitate status).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurocognitive testsAlso: Quality of lifeCohort study: all parents and participants will have questionnaires to complete, based on participant's age. | Other | – |
Primary outcome
Identify risk factors of PICS-p at 2 months post-PICU
Time frame: 2 months after PICU discharge
Identification of modifiable and non-modifiable risk factors
Develop and validate a model predictive of PICS-p 2 months post PICU
Time frame: 2 months after PICU discharge
The model will allow detection at PICU discharge of children in need of post-PICU follow-up
2 secondary outcomes
Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU
Time frame: At 2 months, 12, 18 months and 36 months post PICU discharge
Uncover additional post-PICU morbidities not detected within the framework of PICS-p.
Time frame: Until 36 months post PICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geneviève Du Pont-Tibodeau, MD contact
Laurence Ducharme-Crevier, MD contact
Geneviève Du Pont-Thibodeau, MD principal investigator
St. Justine's Hospital
Laurence Cucharme-Crevier, MD principal investigator
St. Justine's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease and Liver Diseases, run by St. Justine's Hospital at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geneviève Du Pont-Tibodeau, MD (514-345-4931 ext. 5553, genevieve.du.pont-thibodeau.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify risk factors of PICS-p at 2 months post-PICU (time frame: 2 months after PICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.