Clinical trial NCT01490684: Invasive Candidiasis in Saudi ICUs
Official title: Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Candidiasis
Keywords: candidiasis
critically ill
outcomes
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
Collaborators: name: King Fahad Medical City
First posted: 2011-12-13
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients (\> 18 years) admitted to the ICUs of these centers will be evaluated for the occurrence of Candida infection and followed to discharge or death in ICU. The duration of the study will be 12 months. Also patients who had invasive candidiasis within 72 hours of ICU admission will be included.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Mortality
timeFrame: 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.
Secondary outcomes:
measure: ICU Mortality
timeFrame: 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.
measure: Duration of Mechanical Ventilation
timeFrame: date of extubtation minus date of intubation
measure: Length of Stay in the ICU
timeFrame: date of discharge from ICU minus date of admission to ICU
measure: Length of Stay in the Hospital
timeFrame: date of discharge from hospital minus date of admission to hospital
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: King Abdulaziz Medical City
name: Hasan Al-Dorzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Dorzi HM, Sakkijha H, Khan R, Aldabbagh T, Toledo A, Ntinika P, Al Johani SM, Arabi YM. Invasive Candidiasis in Critically Ill Patients: A Prospective Cohort Study in Two Tertiary Care Centers. J Intensive Care Med. 2020 Jun;35(6):542-553. doi: 10.1177/0885066618767835. Epub 2018 Apr 8.