Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit (FPR-IIS)

March 22, 2024 updated by: Oscar Diaz-Cambronero, Hospital Universitario La Fe

Invasive fungal disease in the critically ill patient is a serious complication that increases hospitalization times, morbidity and mortality, and healthcare costs.

Our team proposes a retrospective observational study of patients from the resuscitation unit of the Hospital la Fe who during the years 2016-2019 presented invasive candidiasis. The investigators intend to detect if there are possible specific risk factors that favor the development of invasive candidiasis in colonized patients and if these associated risk factors could be considered as 'triggers' or alerts for the implementation of specific care in these patients.

To do this, the investigators intend to study the blood samples taken from patients, taking into account different types of perioperative variables from them, which will be statistically analyzed, so that evidence-based inferences can be drawn to demonstrate our hypothesis.

Study Overview

Status

Completed

Detailed Description

The hypothesis is that there are factors predisposing to the development of invasive fungal disease, invasive candidiasis, and that the detection of these factors may allow detecting the population at risk and implementing both pharmacological measures and general strategies to reduce the mortality of fungal infection.

Primary objective: To determine if candida auris is associated with increased risk of mortality in invasive fungal disease and the risk factors for mortality in the invasive fungal disease, including the species of candida that causes this disease.

Secondary objectives:

Determination of predictors of mortality in invasive fungal disease. Prepare and validate a score in our environment that allows discriminating those patients with a high risk of mortality.

To analyze the pharmacological management that has been carried out in patients who develop candidemia due to auris.

Detect hospital stays of both population groups, in terms of health management.

Type of study: observational, longitudinal, and retrospective study of cases and controls of a selected exposed population that developed the disease over time or not.

Study Type

Observational

Enrollment (Actual)

134

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

      • Valencia, Spain, 46026
        • Hospital la Fe

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

Sampling Method

Non-Probability Sample

Study Population

The population included in the study will be adult patients over 18 years admitted to the Reanimation unit who present fungal invasive disease during their admission to the unit in the period between May 2016 and January 2019.

Description

Inclusion Criteria:

  • More than 18 years
  • Admitted to the ICU that present fungal invasive disease

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

Cohorts and Interventions

Group / Cohort
Other invasive candida infection
Patients with invasive candida infection due a Candida specie othr than Candida Auris.
Candida Auris related invasive infection
Candida Auris related invasive candida infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients mortality
Time Frame: Hospital stay (up to 6 months)
Number of patients with fungal disease related fatal outcome from diagnosis to end of hospital stay.
Hospital stay (up to 6 months)

Collaborators and Investigators

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

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 (Actual)

May 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • FPR-IIS -029-02 Ed. 03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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