ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs
- Conditions
- Pediatric CancerCritically Ill
- Registration Number
- NCT04581655
- Lead Sponsor
- Azienda Ospedaliera di Padova
- Brief Summary
The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.
- Detailed Description
The study aim to evaluate:
1. characteristics of pediatric cancer patients admitted to Italian PICUs
2. risk factors of PICU admission, neurological outcome and mortality.
Inclusion criteria: age \<= 18 years, informed consent. Exclusion criteria: informed consent not obtained. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months (March 2021 - February 2021) gathering data from 15-20 Italian PICUs. Each Center can decide whether to participate only in the prospective phase. Data will be recorded in an electronic data collection form in Red Cap.
The following variables will be collected:
* Demographic variables: age, sex, ethnicity;
* TIP pre-admission clinical variables and at the time of admission: basic diagnosis, comorbidity, Hemopoietic Stem Cell Transplantation (TCSE) number and type, treatment phase, HLA matching, Graft Versus Host (GVH) and grade, veno-occlusive disease, Venous Occlusive Disease
* Variables upon entering TIP: PIM3, POPC score, organ failure cause and staging, high intensity treatments, high flow oxygen therapy, dialysis, inotropes or other, fluid overload, immunodeficiency
* Clinical variables during hospitalization: organ failure cause and staging, ventilation, modality, presence of pARDS and severity, need for inotropic support, sepsis and severity score (SOFA), inotropes (VIS score), arrest event cardiac, need for HFOV, Extra-Corporeal Membrane Oxygenator, Nitric Oxide, dialysis, Intracranial Pressure monitoring, drugs used for sedation, development of withdrawal syndrome, development of delirium.
Considering the participation of 15-20 centers involving 20 patients in a year, the expected number is 600 patients considering the retrospective phase (optional, therefore some Centers may not contribute) and the prospective phase.
Study sites will also take part to a survey designed to collect data in order to describe Italian PICUs involved in providing care to cancer patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- age <= 18 yeras
- informed consent*
-
informed consent not obtained*
- only for next prospective part of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method neurological outcome on date of PICU discharge assessed up to 10 days patients's Pediatric Overall Performance Category (POPC) score (a 6 level score: 4 to 6 is considered bad outcome)
mortality from 31st to 90th day after PICU discharge 90-days mortality
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Salesi Hospital
🇮🇹Ancona, Italy
University Hospital Policlinico S.Orsola-IRCCS
🇮🇹Bologna, Italy
Meyer Hospital
🇮🇹Firenze, Italy
Children's Hospital V. Buzzi-Sacco
🇮🇹Milano, Italy
Santobono Hospital
🇮🇹Napoli, Italy
Regina Margherita Hospital
🇮🇹Torino, Italy
Di Cristina Hospital
🇮🇹Palermo, Italy
"Bambino Gesù" Children's Hospital
🇮🇹Roma, Italy
University Hospital, Verona
🇮🇹Verona, Italy
Burlo Garofalo Hospital
🇮🇹Trieste, Italy
S.Bortolo Hospital
🇮🇹Vicenza, Italy
Giovanni XIII Hospital
🇮🇹Bergamo, Italy
Spedali Civili Hospital, University of Brescia
🇮🇹Brescia, Italy
I Policlinico
🇮🇹Catania, Italy
Gaslini Hospital
🇮🇹Genova, Italy
University of Messina
🇮🇹Messina, Italy
Azienda Ospedale Università Padova
🇮🇹Padova, Italy