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

October 26, 2016 updated by: Pontificia Universidad Catolica de Chile

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8207257
        • Hospital Dr. Sótero del Río

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with histological diagnosis or high clinical suspicious of cancer, admitted to the intensive care unit

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Standard intensive care unit management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality at 30 days
Time Frame: 30 days since ICU admission
30 days since ICU admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality at 180 days
Time Frame: 180 days since ICU admission
180 days since ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Sebastián Mondaca, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

January 16, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 101015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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