NCT02659839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

January 16, 2016

Last Update Submit

October 26, 2016

Conditions

Keywords

CancerIntensive care unitMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality at 30 days

    30 days since ICU admission

Secondary Outcomes (1)

  • Mortality at 180 days

    180 days since ICU admission

Study Arms (1)

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

Interventions

There will be no change in the standard ICU treatment.

Also known as: Standard intensive care unit management.
Cancer patients admitted to the ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Dr. Sótero del Rio

Santiago, Santiago Metropolitan, 8207257, Chile

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sebastián Mondaca, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2016

First Posted

January 20, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations