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| Name | Class |
|---|---|
| King Fahad Medical City | OTHER_GOV |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital Mortality | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Mortality | If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hasan Al-Dorzi, MD | King Abdulaziz Medical City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City | Riyadh | Saudi Arabia | ||||
| King Fahad Medical City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29628014 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Whole Cohort | The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | The Whole Cohort | The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Mortality | 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. | Posted | Count of Participants | Participants | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Whole Cohort | The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Hasan Al-Dorzi | King Abdulaziz Medical City | 966535888632 | aldorzih@yahoo.com |
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| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
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| Duration of Mechanical Ventilation | 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. | date of extubtation minus date of intubation |
| Length of Stay in the 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. | date of discharge from ICU minus date of admission to ICU |
| Length of Stay in the 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. | date of discharge from hospital minus date of admission to hospital |
| Riyadh |
| Saudi Arabia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | ICU Mortality | If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Duration of Mechanical Ventilation | 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. | Not Posted | date of extubtation minus date of intubation | Participants |
| Secondary | Length of Stay in the 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. | Posted | Mean | Standard Deviation | days | date of discharge from ICU minus date of admission to ICU |
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| Secondary | Length of Stay in the 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. | Posted | Mean | Standard Deviation | days | date of discharge from hospital minus date of admission to hospital |
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| 95 |
| 162 |
| 0 |
| 162 |
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| 162 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |