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

NCT04032743 | Unknown

• 1 other identifier: 0590-18-RMC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oncologic Complications and Emergencies; ICU; Sepsis; Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• survival

  survial status 30 day after release from the ICU

  30 day

Interventions

ICU treatment OTHER

any treatment available by ICU

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Treatment in the hemato-oncology for cancer
• Admission to the ICU in SCMCI between 2008-2018 because of sepsis during chemotherapy

You may not qualify if:

• Admission to the ICU more than 3 month after last chemotherapy or 1 year after SCT

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Emergencies; Sepsis; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Shlomit Barzilai Birenboim, MD

  Schneider Children's Medical Center in Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: October 16, 2018
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

IL (1)