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

• Sponsor: Pontificia Universidad Catolica de Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT02659839
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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	Phase
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

• 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: Jul 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Mortality at 30 days [30 days since ICU admission]

Secondary Outcome Measures

1. Mortality at 180 days [180 days since ICU admission]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Dr. Sótero del Rio	Santiago	Region Metropolitana	Chile	8207257

Sponsors and Collaborators

• Pontificia Universidad Catolica de Chile

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pontificia Universidad Catolica de Chile
• ClinicalTrials.gov Identifier: NCT02659839
• Other Study ID Numbers: 101015
• First Posted: Jan 20, 2016
• Last Update Posted: Oct 27, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Pontificia Universidad Catolica de Chile: Cancer; Intensive care unit; Mortality

Study Results

No Results Posted as of Oct 27, 2016