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OpenTrials
Completed

NCT Number: NCT04581655

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salesi Hospital, Ancona, Italy

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About this study

The study aim to evaluate:

  • characteristics of pediatric cancer patients admitted to Italian PICUs
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age <= 18 yeras
  • informed consent*

Exclusion criteria

  • informed consent not obtained*
  • only for next prospective part of the study

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days

    rate of dead patients

  2. mortality

    Time frame: from discharge to 30th day after PICU discharge

    30-days mortality

  3. mortality

    Time frame: from 31st to 90th day after PICU discharge

    90-days mortality

  4. neurological outcome

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Collaborators

  • University of Padova

Registry information

Official study title

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

Acronym: ONCOTIPNET

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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