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Completed

NCT Number: NCT02659839

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Dr. Sótero del Rio

Santiago, Santiago Metropolitan, 8207257, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Exclusion criteria

  • Absence of cancer recurrences in more than 5 years after diagnosis
  • Functional classification state of 4, according to Eastern Cooperative Oncology Group.

Treatment and study plan

Cancer patients admitted to the ICU

Other

There will be no change in the standard ICU treatment.

Other names: Standard intensive care unit management.

Primary outcomes

  1. Mortality at 30 days

    Time frame: 30 days since ICU admission

Secondary outcomes

  1. Mortality at 180 days

    Time frame: 180 days since ICU admission

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting: A Prospective Cohort Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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