Clinical trial NCT02659839: Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting
Official title: Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Intensive care unit
Mortality
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with histological diagnosis or high clinical suspicious of cancer, admitted to the intensive care unit

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.

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.

Eligibility 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.

Primary outcomes:
measure: Mortality at 30 days
timeFrame: 30 days since ICU admission
Secondary outcomes:
measure: Mortality at 180 days
timeFrame: 180 days since ICU admission
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Dr. Sótero del Rio
state: Region Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Sebastián Mondaca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.