Clinical trial NCT04581655: ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs
Official title: Retrospective and Prospective Analysis of Risk and Outcome Factors in Oncohematological Patients Admitted to Italian Pediatric Intensive Care Units: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Critically Ill
Keywords: pediatric intensive care unit
oncology
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2020-10-09
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients with cancer disease admitted in PICU

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.

Eligibility criteria: Inclusion Criteria:

* age \<= 18 yeras
* informed consent\*

Exclusion Criteria:

* informed consent not obtained\*

  * only for next prospective part of the study

Primary outcomes:
measure: mortality
timeFrame: from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days
measure: mortality
timeFrame: from discharge to 30th day after PICU discharge
measure: mortality
timeFrame: from 31st to 90th day after PICU discharge
measure: neurological outcome
timeFrame: on date of PICU discharge assessed up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Salesi Hospital
city: Bergamo
country: Italy
facility: Giovanni XIII Hospital
city: Bologna
country: Italy
facility: University Hospital Policlinico S.Orsola-IRCCS
city: Brescia
country: Italy
facility: Spedali Civili Hospital, University of Brescia
city: Catania
country: Italy
facility: I Policlinico
city: Firenze
country: Italy
facility: Meyer Hospital
city: Genova
country: Italy
facility: Gaslini Hospital
city: Messina
country: Italy
facility: University of Messina
city: Milano
country: Italy
facility: Children's Hospital V. Buzzi-Sacco
city: Napoli
country: Italy
facility: Santobono Hospital
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
city: Palermo
country: Italy
facility: Di Cristina Hospital
city: Roma
country: Italy
facility: "Bambino Gesù" Children's Hospital
city: Torino
country: Italy
facility: Regina Margherita Hospital
city: Trieste
country: Italy
facility: Burlo Garofalo Hospital
city: Verona
country: Italy
facility: University Hospital, Verona
city: Vicenza
country: Italy
facility: S.Bortolo Hospital
Study officials:
affiliation: University Hospital Padova
name: angela amigoni, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pillon M, Amigoni A, Contin A, Cattelan M, Carraro E, Campagnano E, Tumino M, Calore E, Marzollo A, Mainardi C, Boaro MP, Nizzero M, Pettenazzo A, Basso G, Messina C. Risk Factors and Outcomes Related to Pediatric Intensive Care Unit Admission after Hematopoietic Stem Cell Transplantation: A Single-Center Experience. Biol Blood Marrow Transplant. 2017 Aug;23(8):1335-1341. doi: 10.1016/j.bbmt.2017.04.016. Epub 2017 Apr 28.
citation: Pillon M, Sperotto F, Zattarin E, Cattelan M, Carraro E, Contin AE, Massano D, Pece F, Putti MC, Messina C, Pettenazzo A, Amigoni A. Predictors of mortality after admission to pediatric intensive care unit in oncohematologic patients without history of hematopoietic stem cell transplantation: A single-center experience. Pediatr Blood Cancer. 2019 Oct;66(10):e27892. doi: 10.1002/pbc.27892. Epub 2019 Jun 28.
citation: Wosten-van Asperen RM, van Gestel JPJ, van Grotel M, Tschiedel E, Dohna-Schwake C, Valla FV, Willems J, Angaard Nielsen JS, Krause MF, Potratz J, van den Heuvel-Eibrink MM, Brierley J; POKER (PICU Oncology Kids in Europe Research group) research consortium. PICU mortality of children with cancer admitted to pediatric intensive care unit a systematic review and meta-analysis. Crit Rev Oncol Hematol. 2019 Oct;142:153-163. doi: 10.1016/j.critrevonc.2019.07.014. Epub 2019 Aug 3.
citation: Faraci M, Bagnasco F, Giardino S, Conte M, Micalizzi C, Castagnola E, Lampugnani E, Moscatelli A, Franceschi A, Carcillo JA, Haupt R. Intensive care unit admission in children with malignant or nonmalignant disease: incidence, outcome, and prognostic factors: a single-center experience. J Pediatr Hematol Oncol. 2014 Oct;36(7):e403-9. doi: 10.1097/MPH.0000000000000048.