Mortality in Cancer Patients Admitted to the Intensive Ca... | NCT02659839

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

NCT02659839

Sponsor

Pontificia Universidad Catolica de Chile

Status

Completed

Last Update Posted

Oct 27, 2016Estimated

Enrollment

142Actual

Phase

Not provided

Conditions

Cancer

Interventions

Cancer patients admitted to the ICU

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jan 16, 2016

First Submission Date that Met QC Criteria

Jan 19, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cancer patients admitted to the ICU	Other	There will be no change in the standard ICU treatment.	Cancer patients admitted to the ICU

Measure	Description	Time Frame
Mortality at 30 days		30 days since ICU admission

Measure	Description	Time Frame
Mortality at 180 days		180 days since ICU admission

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastián Mondaca, MD	Pontificia Universidad Catolica de Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Dr. Sótero del Rio		Santiago	Santiago Metropolitan	8207257	Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30582431	Derived	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.