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Invasive Candidiasis in Saudi ICUs (ICIP-SA)

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ClinicalTrials.gov Identifier: NCT01490684
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
King Fahad Medical City
Information provided by (Responsible Party):
Hasan Al-Dorzi, King Abdulaziz Medical City

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Invasive Candidiasis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
The Whole Cohort The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.

Participant Flow:   Overall Study
    The Whole Cohort
STARTED   162 
COMPLETED   162 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
The Whole Cohort The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.

Baseline Measures
   The Whole Cohort 
Overall Participants Analyzed 
[Units: Participants]
 162 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.4  (18.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      77  47.5% 
Male      85  52.5% 
Region of Enrollment 
[Units: Participants]
 
Saudi Arabia   162 


  Outcome Measures

1.  Primary:   Hospital Mortality   [ 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. ]

2.  Secondary:   ICU 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. ]

3.  Secondary:   Length of Stay in the ICU   [ Time Frame: date of discharge from ICU minus date of admission to ICU ]

4.  Secondary:   Length of Stay in the Hospital   [ Time Frame: date of discharge from hospital minus date of admission to hospital ]

5.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: date of extubtation minus date of intubation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Hasan Al-Dorzi
Organization: King Abdulaziz Medical City
phone: 966535888632
e-mail: aldorzih@yahoo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hasan Al-Dorzi, King Abdulaziz Medical City
ClinicalTrials.gov Identifier: NCT01490684     History of Changes
Other Study ID Numbers: KAMC
First Submitted: December 2, 2011
First Posted: December 13, 2011
Results First Submitted: November 30, 2017
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018