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NCT04032743 Clinical Trial

Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis

Sepsis Clinical Trial

Official title:
Retrospective Study: Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04032743
Other study ID # 0590-18-RMC
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 16, 2018
Est. completion date December 2022

Study information
Verified date October 2021
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Children treated with intensive chemotherapy are at increased risk for life-threatening infections (sepsis). As the survival of oncology patients increased with the use of aggressive treatment protocols, there was also an increase in the need for hospitalization in intensive care units (ICU) due to sepsis.Several prognostic factors are known to affect the survival of these patients, including the number and type of damaged systems, the type of oncology disease and the duration of neutropenia. With the development of the treatment of ICU, the survival of the oncology patients hospitalized for sepsis has also increased. We will collect demographic details, details of their oncology and infections, laboratory tests and imaging. The goal is to identify prognostic factors in oncologic children hospitalized in ICU due to sepsis, as well as clinical and laboratory parameters that characterize this group of patients.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 2022
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 19 Years
Eligibility Inclusion Criteria: - Treatment in the hemato-oncology for cancer - Admission to the ICU in SCMCI between 2008-2018 because of sepsis during chemotherapy Exclusion Criteria: - Admission to the ICU more than 3 month after last chemotherapy or 1 year after SCT

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ICU treatment
any treatment available by ICU

Locations
Country Name City State
Israel Schneider Children's Medical Center of Israel Petach Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary survival survial status 30 day after release from the ICU 30 day
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