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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659839
• Other study ID #: 101015
• Status: Completed
• Phase: N/A
• First received: January 16, 2016
• Last updated: October 26, 2016
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Cancer patients admitted to the ICU
There will be no change in the standard ICU treatment.

Locations

Country	Name	City	State
Chile	Hospital Dr. Sótero del Rio	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 30 days		30 days since ICU admission	No
Secondary	Mortality at 180 days		180 days since ICU admission	No