Invasive Candidiasis in Saudi ICUs

Completed

• Conditions: Invasive Candidiasis

• Registration Number: NCT01490684
• Lead Sponsor: Hasan Al-Dorzi

Brief Summary

Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in Saudi Arabia is not well studied. This observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill patients in Saudi Arabia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-10
• Study First Posted: 2011-12-13
• Study Start: 2012-08
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-11
• Results First Submitted: 2017-11-30
• Results First Submitted QC: 2017-11-30
• Last Update Submitted: 2017-11-30
• Results First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• adult patients (> 18 years)
• develop invasive candidiasis as per prespecified definitions during ICU stay
• In addition, patients who had invasive candidiasis within 72 hours of ICU admission will be included

Exclusion Criteria

• Diagnosis of invasive candidiasis (definite or probable) more than 72 hours before ICU admission.
• Diagnosis of invasive candidiasis (definite or probable) within 72 hours of ICU admission, but the admission to ICU for an unrelated reason.
• Readmission to the ICU during the same hospitalization with invasive candidiasis occurring during one of the previous admissions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital Mortality	Patients will be followed while in the ICU and the vital status at the time of discharge from the ICU will be noted. The expected stay in the ICU is 10 days on average.	For patients staying in the ICU for long periods, hospital mortality will be censored at 180 days after entry into the study.That is patient staying alive in the hospital more than 180 days will be considered alive.

Secondary Outcome Measures

Name	Time	Method
ICU Mortality	patients will be followed until discharge from the hospital and vital status at discharge from the hospital will be noted (expected hospital stay is 5 weeks). Hopsital mortality will be censored at 180 days after entry into the study.	If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.
Length of Stay in the ICU	date of discharge from ICU minus date of admission to ICU	Patients will be followed for up to 180 days.Patinets alive in the ICU beyond 180 days of stay will have an ICU length of stay of 180 days.
Duration of Mechanical Ventilation	date of extubtation minus date of intubation	If multiple intubations in the same admission, then the durations of mechanical ventilation will be added.This will be assessed for up to 180 days of stay in the ICU.
Length of Stay in the Hospital	date of discharge from hospital minus date of admission to hospital	Patients will be followed for up to 180 days.Patinets alive in the hospital beyond 180 days of stay will have a hospital length of stay of 180 days.

Trial Locations

Locations (2)

King Fahad Medical City; 🇸🇦 Riyadh, Saudi Arabia

King Abdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia