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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sepsis; Childhood Cancer; ICU; Oncologic Complications and Emergencies
• Intervention / Treatment: Other: ICU treatment

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel
    • Schneider Children's Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and youth treated at Schneider Children's Hospital with chemotherapy due to oncology and hospitalized at Schneider Children's Hospital from 2008 until the end of 2018 due to sepsis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	survial status 30 day after release from the ICU	30 day

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Shlomit Barzilai Birenboim, MD, Schneider Children's Medical Center in Israel

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: 0590-18-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Specific requests for collaborative work and IPD sharing will be considered upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No