Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit

Fungal Invasive Disease Clinical Trial

— FPR-IIS  

Official title:

Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484376
• Other study ID #: FPR-IIS -029-02 Ed. 03
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2024
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• More than 18 years

• Admitted to the ICU that present fungal invasive disease

Related Conditions & MeSH terms

• Fungal Invasive Disease
• Invasive Fungal Infections
• Mycoses

Locations

Country	Name	City	State
Spain	Hospital la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients mortality	Number of patients with fungal disease related fatal outcome from diagnosis to end of hospital stay.	Hospital stay (up to 6 months)