Invasive Candidiasis
Conditions
Keywords
candidiasis, critically ill, outcomes
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.
Interventions
None listed
Sponsors
King Fahad Medical City
Hasan Al-Dorzi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Countries
Saudi Arabia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Whole Cohort The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria. | 162 |
| Total | 162 |
Baseline characteristics
| Characteristic | The Whole Cohort |
|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 18.9 |
| Region of Enrollment Saudi Arabia | 162 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 95 / 162 |
| other Total, other adverse events | 0 / 162 |
| serious Total, serious adverse events | 0 / 162 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Whole Cohort | Hospital Mortality | 95 Participants |
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.
Time frame: date of extubtation minus date of intubation
Secondary
ICU Mortality
If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Whole Cohort | ICU Mortality | 83 Participants |
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.
Time frame: date of discharge from hospital minus date of admission to hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Whole Cohort | Length of Stay in the Hospital | 88.8 days | Standard Deviation 87.2 |
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.
Time frame: date of discharge from ICU minus date of admission to ICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Whole Cohort | Length of Stay in the ICU | 42.4 days | Standard Deviation 54.2 |