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Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting

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ClinicalTrials.gov Identifier: NCT02659839
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Cancer Other: Cancer patients admitted to the ICU

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
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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting: A Prospective Cohort Study
Study Start Date : July 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cancer patients admitted to the ICU
Patients with cancer admitted to the ICU. No intervention will be administered.
 Other: Cancer patients admitted to the ICU
There will be no change in the standard ICU treatment.
Other Name: Standard intensive care unit management.


Outcome Measures
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Primary Outcome Measures :
  1. Mortality at 30 days [ Time Frame: 30 days since ICU admission ]

Secondary Outcome Measures :
  1. Mortality at 180 days [ Time Frame: 180 days since ICU admission ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with histological diagnosis or high clinical suspicious of cancer, admitted to the intensive care unit
Criteria

Inclusion Criteria:

  • 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:

    1. Invasive or non-invasive ventilatory support due to acute respiratory failure.
    2. Use of vasopressor drugs due to hypotension defined as noradrenaline requirement higher than 0.1 microgram/Kg/min.
    3. Renal replacement therapy due to acute renal failure.

Exclusion Criteria:

  • Absence of cancer recurrences in more than 5 years after diagnosis
  • Functional classification state of 4, according to Eastern Cooperative Oncology Group.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659839


Locations
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Chile
Hospital Dr. Sótero del Rio
Santiago, Region Metropolitana, Chile, 8207257
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Sebastián Mondaca, MD Pontificia Universidad Catolica de Chile
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02659839    
Other Study ID Numbers: 101015
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Pontificia Universidad Catolica de Chile:
Cancer
Intensive care unit
Mortality