CancerNCT02659839
Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting
An observational study of Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Cancer patients admitted to the ICU
- How many people
- 142 participants
- Where
- 1 siteChile
- Study dates
- Jul 2015to Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with histological diagnosis or high clinical suspicious of cancer, admitted to the intensive care unit
Who may be able to join
- 18 years-old or older
- Histological diagnosis or high clinical suspicious of cancer (solid /hematological), with the exception of non-melanoma skin cancer.
- Functional classification state between 0-3, according to Eastern Cooperative Oncology Group.
- Admission to intensive care unit, because of one or more of the following criteria:
- Invasive or non-invasive ventilatory support due to acute respiratory failure.
- Use of vasopressor drugs due to hypotension defined as noradrenaline requirement higher than 0.1 microgram/Kg/min.
- Renal replacement therapy due to acute renal failure.
Who cannot join
- Absence of cancer recurrences in more than 5 years after diagnosis
- Functional classification state of 4, according to Eastern Cooperative Oncology Group.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Dr. Sótero del Rio
Santiago, Santiago Metropolitan, 8207257
About this study
Official title: Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting: A Prospective Cohort Study
The purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting.
Read the detailed description
The management of cancer patients in the intensive care unit (ICU) has changed dramatically during the last two decades. Initial experiences showed high rates of hospital mortality, reaching up to 75-85% in patients requiring life-sustaining treatments, particularly mechanical ventilation. An increasing number of clinical experiences has been reported pointing to a significant improvement in survival of these patients. However, it is not clear if this results are generalizable to settings with resource constraints. Therefore, the purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting.
This study is a prospective cohort of cancer patients admitted to the ICU in which the investigators will evaluate the prognostic of cancer patients admitted for a ICU trial or treatment in ICU without limitations. This study will not consider any change in the treatment plan of the patients. The source of the data will be the clinical records of the patients during the admission and the records of the cancer unit. There will be no direct contact of the research team with the patients or their family.
- Conditions
- Cancer
- Being tested
- Cancer patients admitted to the ICU
- Keywords
- Cancer, Intensive care unit, Mortality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer patients admitted to the ICUOther
Also called Standard intensive care unit management.
There will be no change in the standard ICU treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients admitted to the ICU | Patients with cancer admitted to the ICU. No intervention will be administered. Receives: Other: Cancer patients admitted to the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 days
Measured: 30 days since ICU admission
Secondary outcomes (1)
Mortality at 180 days
Measured: 180 days since ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastián Mondaca, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659839
- Sponsor's protocol ID
- 101015
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Panay S, Ruiz C, Abarca M, Nervi B, Salazar I, Caro P, Muniz S, Briones J, Bruhn A, Mondaca S. Mortality of Adult Patients With Cancer Admitted to an Intensive Care Unit in Chile: A Prospective Cohort Study. J Glob Oncol. 2018 Dec;4:1-9. doi: 10.1200/JGO.18.00091.
PubMed 30582431
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02659839
- Acronym / sponsor ID
- 101015
- Conditions
- Cancer
- Keywords
- Cancer, Intensive care unit, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- 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.
The purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting.
Detailed description
The management of cancer patients in the intensive care unit (ICU) has changed dramatically during the last two decades. Initial experiences showed high rates of hospital mortality, reaching up to 75-85% in patients requiring life-sustaining treatments, particularly mechanical ventilation. An increasing number of clinical experiences has been reported pointing to a significant improvement in survival of these patients. However, it is not clear if this results are generalizable to settings with resource constraints. Therefore, the purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting.
This study is a prospective cohort of cancer patients admitted to the ICU in which the investigators will evaluate the prognostic of cancer patients admitted for a ICU trial or treatment in ICU without limitations. This study will not consider any change in the treatment plan of the patients. The source of the data will be the clinical records of the patients during the admission and the records of the cancer unit. There will be no direct contact of the research team with the patients or their family.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients admitted to the ICU | – | Other: Cancer patients admitted to the ICUPatients with cancer admitted to the ICU. No intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with histological diagnosis or high clinical suspicious of cancer, admitted to the intensive care unit
Key inclusion criteria (7 listed)
- 18 years-old or older
- Histological diagnosis or high clinical suspicious of cancer (solid /hematological), with the exception of non-melanoma skin cancer.
- Functional classification state between 0-3, according to Eastern Cooperative Oncology Group.
- Admission to intensive care unit, because of one or more of the following criteria:
Key exclusion criteria (2 listed)
- Absence of cancer recurrences in more than 5 years after diagnosis
- Functional classification state of 4, according to Eastern Cooperative Oncology Group.
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 |
|---|---|---|
| Cancer patients admitted to the ICUAlso: Standard intensive care unit management.There will be no change in the standard ICU treatment. | Other | Cancer patients admitted to the ICU |
Primary outcome
Mortality at 30 days
Time frame: 30 days since ICU admission
1 secondary outcome
Mortality at 180 days
Time frame: 180 days since ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 30582431Panay S, Ruiz C, Abarca M, Nervi B, Salazar I, Caro P, Muniz S, Briones J, Bruhn A, Mondaca S. Mortality of Adult Patients With Cancer Admitted to an Intensive Care Unit in Chile: A Prospective Cohort Study. J Glob Oncol. 2018 Dec;4:1-9. doi: 10.1200/JGO.18.00091.
- Individual participant dataSharing planned: Undecided
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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.
Sebastián Mondaca, MD principal investigator
Pontificia Universidad Catolica de Chile
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 Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 27 Oct 2016. 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality at 30 days (time frame: 30 days since ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659839, which also lists 1 linked publication.
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 27 Oct 2016.