ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs

Critically Ill Clinical Trial

— ONCOTIPNET  

Official title:

Retrospective and Prospective Analysis of Risk and Outcome Factors in Oncohematological Patients Admitted to Italian Pediatric Intensive Care Units: a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581655
• Other study ID #: ONCOTIPNET
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliera di Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• age <= 18 yeras

• informed consent*

Exclusion Criteria:

• informed consent not obtained*

• only for next prospective part of the study

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Pediatric Cancer

Locations

Country	Name	City	State
Italy	Salesi Hospital	Ancona
Italy	Giovanni XIII Hospital	Bergamo
Italy	University Hospital Policlinico S.Orsola-IRCCS	Bologna
Italy	Spedali Civili Hospital, University of Brescia	Brescia
Italy	I Policlinico	Catania
Italy	Meyer Hospital	Firenze
Italy	Gaslini Hospital	Genova
Italy	University of Messina	Messina
Italy	Children's Hospital V. Buzzi-Sacco	Milano
Italy	Santobono Hospital	Napoli
Italy	Azienda Ospedale Università Padova	Padova
Italy	Di Cristina Hospital	Palermo
Italy	"Bambino Gesu`" Children's Hospital	Roma
Italy	Regina Margherita Hospital	Torino
Italy	Burlo Garofalo Hospital	Trieste
Italy	University Hospital, Verona	Verona
Italy	S.Bortolo Hospital	Vicenza

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova	University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 fact — View 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 Hemat — View 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 he — View Citation

Wösten-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 consortiu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	rate of dead patients	from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days
Primary	mortality	30-days mortality	from discharge to 30th day after PICU discharge
Primary	mortality	90-days mortality	from 31st to 90th day after PICU discharge
Primary	neurological outcome	patients's Pediatric Overall Performance Category (POPC) score (a 6 level score: 4 to 6 is considered bad outcome)	on date of PICU discharge assessed up to 10 days