Oncologic Complications and EmergenciesNCT04032743
Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis
An observational study of Oncologic Complications and Emergencies and ICU, run by Rabin Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Oncologic Complications and Emergencies, ICU, Sepsis
- What is being tested?
- ICU treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Oct 2018to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Treatment in the hemato-oncology for cancer
- Admission to the ICU in SCMCI between 2008-2018 because of sepsis during chemotherapy
Who cannot join
- Admission to the ICU more than 3 month after last chemotherapy or 1 year after SCT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Oncologic Complications and Emergencies, ICU, Sepsis, Childhood Cancer
- Being tested
- ICU treatment
- Medical subject headings
- Emergencies, Sepsis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU treatmentOther
any treatment available by ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
survial status 30 day after release from the ICU
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start16 Oct 2018
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic Complications and EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shlomit Barzilai Birenboim, MD, Principal investigator, Schneider Children's Medical Center in Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032743
- Sponsor's protocol ID
- 0590-18-RMC
- Status last verified
- Oct 2021
- First submitted
- 23 Jul 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Specific requests for collaborative work and IPD sharing will be considered upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study: Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis
- ClinicalTrials.gov ID
- NCT04032743
- Acronym / sponsor ID
- 0590-18-RMC
- Conditions
- Oncologic Complications and Emergencies, ICU, Sepsis, Childhood Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Treatment in the hemato-oncology for cancer
- Admission to the ICU in SCMCI between 2008-2018 because of sepsis during chemotherapy
Key exclusion criteria (1 listed)
- Admission to the ICU more than 3 month after last chemotherapy or 1 year after SCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU treatmentany treatment available by ICU | Other | – |
Primary outcome
survival
Time frame: 30 day
survial status 30 day after release from the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Undecided. Specific requests for collaborative work and IPD sharing will be considered upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Barzilai Birenboim, MD principal investigator
Schneider Children's Medical Center in Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Complications and Emergencies and ICU, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.