Invasive Candidiasis in ICU (ICIP-SA)
This study is currently recruiting participants.
Verified August 2012 by King Abdulaziz Medical City
Information provided by (Responsible Party):
Hasan Al-Dorzi, King Abdulaziz Medical City
First received: December 2, 2011
Last updated: August 13, 2012
Last verified: August 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
Primary Outcome Measures:
Secondary Outcome Measures:
- hospital mortality [ Time Frame: 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. ] [ Designated as safety issue: No ]
If patients are still alive at 180 days after entring the sudy, they will be considered hospital survivors.
- duration of mechanical ventilation [ Time Frame: date of extubtation minus date of intubation ] [ Designated as safety issue: No ]
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 ICU [ Time Frame: date of discharge from ICU minus date of admission to ICU ] [ Designated as safety issue: No ]
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.
- length of stay in the hospital [ Time Frame: date of discharge from hospital minus date of admission to hospital ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490684
|King Abdulaziz Medical City
|Riyadh, Saudi Arabia |
|Contact: Hasan Al-Dorzi, MD 966535888632 firstname.lastname@example.org |
|Sub-Investigator: Yaseen Arabi, MD |
|Sub-Investigator: Raymond Khan, MD |
|Sub-Investigator: Sameera Al-Johani, MD |
|Sub-Investigator: Tarek Al-Dabbagh, MD |
||Hasan Al-Dorzi, MD
||King Abdulaziz Medical City
No publications provided
||Hasan Al-Dorzi, Consultant, Intensive Care Department, King Abdulaziz Medical City
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2011
||August 13, 2012
||King Abdullah International Medical Research Center, Riyadh, Saudi Arabia:
Keywords provided by King Abdulaziz Medical City:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 21, 2014